Health product recalls and alerts, 2014
1,253 notices, newest first. Each links to the official notice.
Drugs, vaccines and biologics
- "Jetfuel Superburn" recalled after Health Canada tests find undeclared drug ingredientsDecember 24, 2014 · Drugs
- Health products quarantined from two sites in India as Health Canada assesses data integrity concernsDecember 23, 2014 · Drugs · Product quality
- Lignospan Standard and Oraverse (2014-12-12)December 23, 2014 · Drugs · Product safety · Type I
- STERRAD Product Recall (2014-12-08)December 12, 2014 · Drugs · Product safety · Type II
- A.C.& C 8 mg Tab (2014-12-01)December 12, 2014 · Drugs · Product safety · Type III
- Praxis AC&C Tablets (2014-12-04)December 12, 2014 · Drugs · Product safety · Type III
- Additional dangerous products from Rapha Biotech Inc. found at "ShopForYou" in VancouverDecember 5, 2014 · Drugs · Undeclared substance
- LiLash 0.2 oz (Eyelash Conditioner) (2014-10-09)December 3, 2014 · Drugs · Product safety · Type II
- Mitoxantrone injection USP (2014-11-21)December 2, 2014 · Drugs · Product safety · Type II
- Health Canada reminds Canadians not to use unauthorized health productsNovember 28, 2014 · Drugs
- Information Update - Marijuana for Medical Purposes - Advertising and Licensed ProducersNovember 25, 2014 · Drugs · Product safety
- STELARA (ustekinumab) - Risk of Rare Serious Skin Conditions - For Health ProfessionalsNovember 21, 2014 · Biologic or vaccine · Product safety
- FERAHEME (ferumoxytol) - Important Changes to the Delivery and New Restrictions on the Use Due to Information on Serious Allergic Reactions - For the PublicNovember 21, 2014 · Drugs · Product safety
- STELARA (ustekinumab) - Risk of Rare Serious Skin Conditions - For the PublicNovember 21, 2014 · Biologic or vaccine · Product safety
- FERAHEME (ferumoxytol) - Important Changes to the Delivery and New Restrictions on the Use Due to Information on Serious Allergic Reactions - For Health ProfessionalsNovember 21, 2014 · Drugs · Product safety
- IMOVANE (zopiclone) - New Dosage Recommendations to Minimize the Risk of Next-Day Impairment - For the PublicNovember 19, 2014 · Drugs · Product safety
- IMOVANE (zopiclone) - New Dosage Recommendations to Minimize the Risk of Next-Day Impairment - For Health ProfessionalsNovember 19, 2014 · Drugs · Product safety
- Health Canada reviewing possible safety concerns with certain long-term antiplatelet (blood thinner) therapy; Benefits of treatment still outweigh potential risksNovember 18, 2014 · Drugs · Product safety
- REMINYL ER (galantamine hydrobromide) - New Safety Information Regarding the Risk of Serious Skin Reactions - For Health ProfessionalsNovember 18, 2014 · Drugs · Product safety
- REMINYL ER (galantamine hydrobromide) - New Safety Information Regarding the Risk of Serious Skin Reactions - For the PublicNovember 18, 2014 · Drugs · Product safety
- Prostaglandin Analogues Recall (2014-10-06)November 7, 2014 · Drugs · Product safety · Type II
- Pro-Derm SPF Recall (2014-10-27)November 6, 2014 · Drugs · Product safety · Type III
- Sucrets Extra Strength Cherry DM (2014-10-22)November 6, 2014 · Drugs · Product safety · Type III
- Health Canada takes action to restrict import of products from three Micro Labs facilities in IndiaOctober 27, 2014 · Drugs · Product safety
- Yervoy (2014-10-17)October 22, 2014 · Health products · Product safety · Type I
- Cosmetic Pros Recall (2014-10-06)October 22, 2014 · Drugs · Product safety · Type II
- Mylan-Nitro Sublingual Spray (2014-10-14)October 22, 2014 · Drugs · Product safety · Type I
- Torisel (2014-10-06)October 22, 2014 · Drugs · Product safety · Type III
- Lashes to Die For Platinum (2014-10-16)October 22, 2014 · Drugs · Product safety · Type II
- YERVOY 200 mg/40 mL (5 mg/mL) (Ipilimumab for injection), single-use vial - Recall of 2 Lots Due to Cracked Vials - Notice to HospitalsOctober 18, 2014 · Biologic or vaccine · Product safety
- Updated consumer information on Mylan Pharmaceuticals nitroglycerin spray recallOctober 15, 2014 · Drugs · Product safety
- Mylan-Nitro Sublingual Spray 0.4 mg Per Metered Dose - Unaffected Product Has Now Become Available - For Health ProfessionalsOctober 14, 2014 · Drugs · Product safety
- Buscopan Tablets 10 mg (2014-10-02)October 10, 2014 · Drugs · Product safety · Type II
- Safety information on the risk of blood clots with immunoglobulin productsOctober 9, 2014 · Biologic or vaccine · New safety information - Product safety
- Non-Hyperimmune Immunoglobulin Products - Changes to Canadian Product Monographs - Notice to HospitalsOctober 9, 2014 · Biologic or vaccine · Product safety
- Diclofenac - Update to Heart and Stroke Related Safety Information and Decrease in the Maximum Recommended Daily Dose for Tablets and Suppositories - For the PublicOctober 6, 2014 · Drugs · Product safety
- Diclofenac - Update to Heart and Stroke Related Safety Information and Decrease in the Maximum Recommended Daily Dose for Tablets and Suppositories - For Health ProfessionalsOctober 6, 2014 · Drugs · Product safety
- Biomedic Acetaminophen with Codeine (2014-09-28)October 3, 2014 · Drugs · Product safety · Type I
- Health Canada takes action to stop import of products from three sites in IndiaSeptember 30, 2014 · Drugs · Product safety
- Ceftriaxone Sodium 10 g/vial (2014-09-25)September 30, 2014 · Health products · Product safety · Type I
- Acid Concentrate (2014-09-18)September 29, 2014 · Drugs · Product safety · Type I
- Adalat XL (2014-09-02)September 29, 2014 · Drugs · Product safety · Type III
- Calcium-45 0.5-4.5 (2014-09-20)September 29, 2014 · Drugs · Product safety
- Sani-Cloth AF3 Germicidal Disposable Wipe (2014-09-12)September 29, 2014 · Drugs · Product safety · Type III
- Dopamine HCl (2014-09-17)September 29, 2014 · Drugs · Product safety · Type I
- Biomedic Acetaminophen with Codeine: Recall Due To Missing Child-Resistant PackagingSeptember 28, 2014 · Drugs
- Ceftriaxone for Injection 10 g/vial - Recall of Seven Lots Due to Particulate Matter - Notice to HospitalsSeptember 26, 2014 · Drugs · Product safety
- Health Canada requests quarantine of products for Canadian market from Apotex facility in Bangalore, IndiaSeptember 24, 2014 · Drugs · Product quality
- Mylan-Nitro Sublingual Spray 0.4 mg Per Metered Dose - Additional Information on the Recall - For Health ProfessionalsSeptember 22, 2014 · Drugs · Product safety
- Baxter Calcium-45, 24 EA/CA - Recall of One (1) Lot Due to Missing Bottle Labels - Notice to HospitalsSeptember 21, 2014 · Drugs · Labelling - Product safety
- Baxter recalls certain lots of hemodialysis solutions due to particulate matter found in the productSeptember 19, 2014 · Drugs · Contamination
- Acid Concentrate 45X - Urgent Product Recall for Two (2) Lots due to Particulate Matter - For Health ProfessionalsSeptember 19, 2014 · Drugs · Contamination - Product safety
- Health Canada requests quarantine of products from IPCA Laboratories following falsification and manipulation of data issuesSeptember 17, 2014 · Drugs
- Sucrets for Kids (2014-08-29)September 15, 2014 · Drugs · Product safety · Type II
- Extra Strength Allergy Total (2014-08-28)September 15, 2014 · Drugs · Product safety · Type III
- Mint-Rosuvastatin (2014-08-27)September 15, 2014 · Drugs · Product safety · Type III
- Dacarbazine for Injection 600 mg/vial, BP - Discoloration After Reconstitution of Vials - Notice to HospitalsSeptember 9, 2014 · Drugs · Product safety
- Serophene (2014-08-26)September 2, 2014 · Drugs · Product safety · Type II
- Velcade (2014-08-12)September 2, 2014 · Drugs · Product safety · Type II
- Apo-Mycophenolic Acid (2014-08-15)September 2, 2014 · Drugs · Product safety · Type II
- AMSA PD Inj 50 mg/mL - Potential Low Risk of Microbial Contamination - Notice to HospitalsAugust 29, 2014 · Drugs · Contamination
- Label changes for controlled-release opioid pain medicines encourage more targeted prescribing and safer useAugust 18, 2014 · Health products
- Apotex recalling one lot of Apo-Mycophenolic Acid due to French labelling errorAugust 16, 2014 · Health products · Labelling
- Apo-Mycophenolic Acid 360 mg (DIN 02372746 Lot KY6601) - Recall of One Lot due to French Labelling Error - For Health ProfessionalsAugust 16, 2014 · Health products · Labelling
- Recall of Marijuana for Medical Purposes - Whistler Medical Marijuana Corp.August 15, 2014 · Drugs · Contamination
- Pre-Attached LTA Kit 4% Lidocaine Hydrochloride Topical Solution USP (2014-07-31)August 12, 2014 · Drugs · Product safety · Type I
- HMTS Sterilant Agent (2014-07-04)August 12, 2014 · Drugs · Product safety · Type III
- Proctol suppositories (2014-06-23)August 12, 2014 · Drugs · Product safety · Type III
- Atorvastatin Recall (2014-07-08)August 12, 2014 · Drugs · Product safety · Type II
- ARZERRA (ofatumumab) - Fatal Infusion Reaction Reported in a Patient with Chronic Lymphocytic Leukemia - For Health ProfessionalsAugust 6, 2014 · Biologic or vaccine · Product safety
- ARZERRA (ofatumumab) - Fatal Infusion Reaction Reported in a Patient with Chronic Lymphocytic Leukemia - For the PublicAugust 6, 2014 · Biologic or vaccine · Product safety
- Pre-Attached LTA Kit 4% Lidocaine Hydrochloride Topical Solution USP - Recall due to Cannula Breakage - Notice to HospitalsAugust 1, 2014 · Drugs · Product quality - Product safety
- NUVARING (etonogestrel / ethinyl estradiol slow release vaginal ring) - New Usage Restrictions - For Health ProfessionalsJuly 31, 2014 · Drugs · Product safety
- NUVARING (etonogestrel / ethinyl estradiol slow release vaginal ring) - New Usage Restrictions - For the PublicJuly 31, 2014 · Drugs · Product safety
- Cytarabine Injection 2g / 20mL - Missing or Partially Detached Label - Notice to HospitalsJuly 30, 2014 · Drugs · Labelling - Product safety
- DURAGESIC MAT (fentanyl transdermal system) - Introduction of a Single Ink Colour (Dark Green) on all Strengths of Patches - For the PublicJuly 28, 2014 · Drugs · Product safety
- DURAGESIC MAT (fentanyl transdermal system) - Introduction of a Single Ink Colour (Dark Green) on all Strengths of Patches - For Health ProfessionalsJuly 28, 2014 · Drugs · Product safety
- DURAGESIC MAT (fentanyl transdermal system) - Introduction of a Single Ink Colour (Dark Green) on all Strengths of Patches - Notice to HospitalsJuly 28, 2014 · Drugs · Product safety
- Safe use of topical antiseptics for preoperative and preinjection skin preparationJuly 25, 2014 · Drugs · Contamination - Product safety
- Spiriva (2013-10-07)July 25, 2014 · Drugs · Product safety · Type III
- Citalopram-10, Methylphenidate recall (2014-07-08)July 17, 2014 · Drugs · Product safety · Type I
- ratio-Atorvastatin recall (2014-07-08)July 17, 2014 · Drugs · Product safety · Type II
- Information Update - Possible cardiovascular problems associated with testosterone productsJuly 15, 2014 · Drugs · Product safety
- HMTS Sterilant Agent (2014-06-06)July 11, 2014 · Drugs · Product safety · Type III
- Glucovision (2014-06-19)July 11, 2014 · Drugs · Product safety · Type II
- Cellfood (2014-06-11)July 11, 2014 · Drugs · Product safety · Type II
- Soliris (2014-06-06)July 11, 2014 · Drugs · Product safety · Type II
- Aubagio (2014-06-09)July 11, 2014 · Drugs · Product safety · Type III
- FERAHEME (ferumoxytol) - New Restrictions on the Use due to Information on Serious Allergic Reactions - For Health ProfessionalsJuly 11, 2014 · Drugs · Product safety
- FERAHEME (ferumoxytol) - New Restrictions on the Use due to Information on Serious Allergic Reactions - For the PublicJuly 11, 2014 · Drugs · Product safety
- Clinimix Recall (2014-05-29)June 24, 2014 · Drugs · Product safety · Type I
- Cellfood (2014-06-20)June 20, 2014 · Drugs · Product safety · Type II
- Naturalyte Recall (2014-04-29)June 17, 2014 · Drugs · Product safety · Type III
- Zofran (ondansetron) - Dosage and Administration of Intravenous Ondansetron in Geriatrics (>65 years of age) - For Health ProfessionalsJune 12, 2014 · Drugs · Product safety
- TERAZOL 7 Vaginal Cream 0.4% (terconazole); TERAZOL 3 Dual-Pak - Vaginal Cream 0.8%/Vaginal Ovules 80 mg (terconazole) - Risk of Anaphylaxis and Toxic Epidermal Necrolysis - For Health ProfessionalsJune 9, 2014 · Drugs · Product safety
- TERAZOL 7 Vaginal Cream 0.4% (terconazole); TERAZOL 3 Dual-Pak - Vaginal Cream 0.8%/Vaginal Ovules 80 mg (terconazole) - Risk of Anaphylaxis and Toxic Epidermal Necrolysis - For the PublicJune 9, 2014 · Drugs · Product safety
- Health Canada Suspends Licence of "CanadaDrugs.com LP"June 9, 2014 · Drugs · Product safety
- Heartland Natural Wild Yam Moisturizing Cream (2014-05-23)May 29, 2014 · Drugs
- Clinimix 5% TRAVASOL Amino Acid Injection - Expanded Recall to Include Four Additional Products/Lots due to Particulate Matter Found in the Solution - Notice to HospitalsMay 29, 2014 · Drugs · Contamination
- Sodium Chloride Irrigation 9mg/mL (2014-05-16)May 29, 2014 · Drugs · Product safety · Type I
- Foreign Product Alerts: Dr. Mao Slimming Capsules, Perfect Body Solutions, Burn 7, Bella Vi Insane Amp'd, Bella Vi Amp'd Up, Be Inspired, Goodliness Fat-Reducing Capsules, Jimpness Beauty Fat Loss CapsulesMay 28, 2014 · Drugs · Undeclared substance
- Foreign Product Alerts: Prolifta Capsules, PHUK and Virilis ProMay 28, 2014 · Drugs · Undeclared substance
- Foreign Product Alert: VitaliKORMay 28, 2014 · Drugs · Undeclared substance
- Foreign Product Alerts: Wood-E, Xzen Gold, Xzen XPress, XZen 1200, and XZone PremiumMay 28, 2014 · Drugs · Undeclared substance
- Foreign Product Alert: Vigor Tea sachetsMay 28, 2014 · Drugs · Undeclared substance
- PMS-Losartan-HCTZ (2014-05-23)May 28, 2014 · Drugs · Product safety · Type I
- Foreign Product Alerts: Nature Most Laboratories Vanilla Almond, and Strawberry Banana Whey Power productsMay 28, 2014 · Drugs · Undeclared substance
- Foreign Product Alerts: Slim Fortune, Lidiy, and Slim ExpertMay 28, 2014 · Drugs · Undeclared substance
- DermOtic Oil Ear Drops (2014-03-20)May 28, 2014 · Drugs · Product safety · Type III
- Derma-Smoothe/FS (2014-03-20)May 28, 2014 · Drugs · Product safety · Type III
- VECTIBIX (panitumumab) - Rare Cases of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis - For the PublicMay 27, 2014 · Biologic or vaccine · Product safety
- VECTIBIX (panitumumab) - Rare Cases of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis - For Health ProfessionalsMay 27, 2014 · Biologic or vaccine · Product safety
- Calcijex (2014-05-21)May 26, 2014 · Drugs · Product safety · Type I
- Heartland Natural Wild Yam Moisturizing Cream contains undisclosed prescription drug ingredientMay 23, 2014 · Drugs · Undeclared substance
- Hypertension drug PMS-Losartan-HCTZ recalled due to labelling errorMay 23, 2014 · Drugs · Labelling
- Apo-Risperidone (2014-05-12)May 22, 2014 · Drugs · Product safety · Type III
- Short Ragweed Pollen (Allergenic Extract Pollens) (2014-05-12)May 22, 2014 · Drugs · Product safety · Type III
- Novo-Risperidone (2014-05-06)May 22, 2014 · Drugs · Product safety · Type II
- Hospira Sodium Chloride 0.9% Irrigation, USP, 3000 mL Flexible Container (DIN 00037826, Lot 29037JT) - Recall of One Lot - Notice to HospitalsMay 17, 2014 · Drugs
- New safety information: Risk of serotonin syndrome associated with serotonin blocking drugs used to treat nausea and vomitingMay 14, 2014 · Drugs · Product safety
- Recall of Marijuana for Medical Purposes - Peace Naturals Project Inc.May 9, 2014 · Drugs · Contamination
- Health Canada Confirms License Suspension of Biolyse Pharma for Serious Manufacturing Concerns - Supply of paclitaxel will not be disrupted for Canadian patientsMay 9, 2014 · Drugs · Product safety
- TEMODAL (temozolomide) - Risk of Liver Problems - For the PublicMay 7, 2014 · Drugs · Product safety
- TEMODAL (temozolomide) - Risk of Liver Problems - For Health ProfessionalsMay 7, 2014 · Drugs · Product safety
- Taro-Docusate Capsules USP 100 mg (2014-04-25)May 2, 2014 · Drugs · Product safety · Type II
- Recall of Paxil Products (2014-04-08)May 1, 2014 · Drugs · Product safety · Type III
- BENLYSTA (belimumab) - Progressive Multifocal Leukoencephalopathy Reported in Patients - For the PublicApril 28, 2014 · Biologic or vaccine · Product safety
- BENLYSTA (belimumab) - Progressive Multifocal Leukoencephalopathy Reported in Patients - For Health ProfessionalsApril 28, 2014 · Biologic or vaccine · Product safety
- New lots recalled: Fresenius Medical Care continues recall of Sodium Bicarbonate Liquid ConcentrateApril 23, 2014 · Drugs · Contamination
- Clinimix (2014-04-08)April 23, 2014 · Drugs · Product safety · Type I
- Recall of Marijuana for Medical Purposes - Greenleaf MedicinalsApril 18, 2014 · Drugs
- Clinimix - 5% TRAVASOL Amino Acid Injection WITH Electrolytes in 16.6% Dextrose Injection, 1 L - Recall Due to Particulate Matter Found in the Solution - Notice to HospitalsApril 17, 2014 · Drugs · Contamination
- Potentially dangerous unauthorized drugs seized from "SVN FUEL" stores in B.C.April 11, 2014 · Drugs · Unauthorized product
- Cefazolin for Injection USP 1g - Potential for Longer Reconstitution Time and Precipitation of the Reconstituted Solution - Notice to HospitalsApril 10, 2014 · Drugs · Product safety
- Neupogen (filgrastim) and Neulasta (pegfilgrastim) - Risk of Capillary Leak Syndrome - For Health ProfessionalsApril 10, 2014 · Biologic or vaccine · Product safety
- Neupogen (filgrastim) and Neulasta (pegfilgrastim) - Risk of Capillary Leak Syndrome - For the PublicApril 10, 2014 · Biologic or vaccine · Product safety
- Potentially dangerous weight-loss product seized from U-Box store in Burnaby, BCApril 9, 2014 · Drugs · Undeclared substance
- Fresenius Medical Care expands recall of Sodium Bicarbonate Liquid ConcentrateApril 9, 2014 · Drugs · Contamination
- NaturaLyte Sodium Bicarbonate Liquid Concentrate (2014-04-04)April 9, 2014 · Drugs · Product safety · Type I
- Riva-Pantoprazole (2014-04-03)April 8, 2014 · Drugs · Product safety · Type III
- dom-Pantoprazole (2014-04-04)April 8, 2014 · Drugs · Product safety · Type II
- pms-Pantoprazole (2014-04-01)April 8, 2014 · Drugs · Product safety · Type II
- ZELBORAF (vemurafenib) - Association with Liver Problems - For Health ProfessionalsApril 7, 2014 · Drugs · Product safety
- ZELBORAF (vemurafenib) - Association with Liver Problems - For the PublicApril 7, 2014 · Drugs · Product safety
- BUSULFEX (busulfan) 6 mg/mL Injection - Potential for Particulate Matter in 10 mL vials - Notice to HospitalsApril 7, 2014 · Drugs · Contamination
- Voluntary recall: NaturaLyte Sodium Bicarbonate Liquid ConcentrateApril 5, 2014 · Drugs · Contamination
- Hill Dermaceuticals Inc. Recall (2014-03-20)April 4, 2014 · Drugs · Product safety · Type III
- Fluconazole Injection SDZ (2014-03-25)April 4, 2014 · Drugs · Product safety · Type III
- REMERON / REMERON RD (mirtazapine) - Abnormal Heart Rhythm - For the PublicMarch 28, 2014 · Drugs · Product safety
- REMERON / REMERON RD (mirtazapine) - Abnormal Heart Rhythm - For Health ProfessionalsMarch 28, 2014 · Drugs · Product safety
- Foreign Product Alert: ZyrexinMarch 27, 2014 · Drugs · Undeclared substance
- Foreign Product Alerts: Majestic Slim Perfect and Yixiu L-Carnitine Slimming CapsulesMarch 26, 2014 · Drugs · Undeclared substance
- Foreign Product Alerts: Various Sexual Enhancement ProductsMarch 26, 2014 · Drugs · Undeclared substance
- Emergency contraceptive pills to carry warnings for reduced effectiveness in women over a certain body weightMarch 26, 2014 · Drugs · Product safety
- Foreign Product Alerts: Xiang Gang Tian Long Sheng Wu Ke Ji Di Qi Dai Chi Jiu Zhan ShenMarch 26, 2014 · Drugs · Undeclared substance
- IMURAN (azathioprine) or PURINETHOL (mercaptopurine) - Association with a Type of Blood Cancer - Hepatosplenic T-Cell Lymphoma - For the PublicMarch 26, 2014 · Drugs · Product safety
- IMURAN (azathioprine) or PURINETHOL (mercaptopurine) - Association with a Type of Blood Cancer - Hepatosplenic T-Cell Lymphoma - For Health ProfessionalsMarch 26, 2014 · Drugs · Product safety
- Roid Nutrition Recall (2014-03-06)March 25, 2014 · Drugs · Product safety · Type II
- BMD 110G (2014-03-10)March 21, 2014 · Veterinary drugs · Product safety · Type III
- Myochrysine (2014-03-12)March 21, 2014 · Drugs · Product safety · Type II
- Hycodan Tablets (2014-03-03)March 21, 2014 · Drugs · Product safety · Type II
- PMS Diltiazem CD (2014-02-21)March 14, 2014 · Drugs · Product safety · Type III
- IGIVnex (2012-02-25)March 14, 2014 · Drugs · Product safety · Type II
- Diltiazem-CD 300 mg capsules (2014-02-20)March 14, 2014 · Drugs · Product safety · Type III
- Apo-Diltiaz CD (2014-02-21)March 10, 2014 · Drugs · Product safety · Type III
- Evra (2014-02-27)March 10, 2014 · Drugs · Product safety · Type I - Type II
- Kenalog-40 Injection (2014-03-04)March 4, 2014 · Drugs · Product safety · Type II
- Herbal detox and laxative products Formule L1 and Detox Spring Fall recalled due to missing risk statements on labelFebruary 27, 2014 · Drugs · Labelling
- Apo-Naproxen Tablets (2014-02-18)February 25, 2014 · Drugs · Product safety · Type II
- Naproxen 500 mg tablet (2014-02-14)February 25, 2014 · Drugs · Product safety · Type II
- New safety information for antiviral drug used in the treatment of HIVFebruary 19, 2014 · Drugs · New safety information
- Foreign Product Alert: HairegeneratorFebruary 18, 2014 · Drugs · Undeclared substance
- Foreign Product Alerts: Lightning 10.0+, LV Shou Reduces Fat; and STB Summit of the Thin Body S Woman Degreasing Burning PillFebruary 18, 2014 · Drugs · Undeclared substance
- Foreign Product Alerts: Li Long Mei Guo Mo Bang, and Ginseng Tu chong Wan Lin HeongFebruary 18, 2014 · Drugs · Undeclared substance
- Botulism in infants - information for parents and caregiversFebruary 12, 2014 · Drugs
- Cosopt (dorzolamide hydrochloride/timolol maleate) Preservative-Free Ophthalmic Solution - Risk of Eye Injury - For Health ProfessionalsFebruary 7, 2014 · Drugs · Product safety
- Cosopt (dorzolamide hydrochloride/timolol maleate) Preservative-Free Ophthalmic Solution - Risk of Eye Injury - For the PublicFebruary 7, 2014 · Drugs · Product safety
- New safety information for lithium drugs and the risk of high blood calcium and hyperparathyroidismFebruary 5, 2014 · Drugs · New safety information
- Lithium - Risk of Hypercalcemia and Hyperparathyroidism - For Health ProfessionalsFebruary 5, 2014 · Drugs · New safety information
- New warnings regarding blood pressure drugsFebruary 4, 2014 · Drugs · New safety information
- Products containing undeclared prescription drugs removed from Burnaby West Box storeFebruary 3, 2014 · Drugs · Undeclared substance - Unauthorized product
- Health Canada evaluating whether body weight affects the effectiveness of emergency contraceptive pillJanuary 30, 2014 · Drugs · Dosage
- Sandoz Glimepiride (2014-01-24)January 28, 2014 · Drugs · Product safety · Type I
- ARZERRA (ofatumumab) - Recommendations to Screen, Monitor and to Manage Hepatitis B Virus Reactivation - For the PublicJanuary 27, 2014 · Biologic or vaccine · Product safety
- ARZERRA (ofatumumab) - Recommendations to Screen, Monitor and to Manage Hepatitis B Virus Reactivation - For Health ProfessionalsJanuary 27, 2014 · Biologic or vaccine · Product safety
- Sandoz Glimepiride recalled due to mislabelling of dosage strength on packagingJanuary 24, 2014 · Drugs
- EFFIENT (prasugrel hydrochloride) - Association with Increased Risk of Bleeding in Patients Treated in Hospital for Certain Types of Heart Attacks - For the PublicJanuary 17, 2014 · Drugs · Product safety
- EFFIENT (prasugrel hydrochloride) - Association with Increased Risk of Bleeding in Patients Treated in Hospital for Certain Types of Heart Attacks - For Health ProfessionalsJanuary 17, 2014 · Drugs · Product safety
- Apo-Diltiaz CD (2013-12-17)January 16, 2014 · Drugs · Product safety · Type III
- Hospira Flexible Intravenous Containers - Potential for Leakage in Certain Lots (1000 mL Intravenous Bags - Sodium Chloride 0.9% Injection USP and Dextrose 5% Injection USP) - For Health ProfessionalsJanuary 14, 2014 · Drugs · Product safety
- Sandoz Liquid Injectable Products - Potential Presence of Particulate Matter in Glass Vials - For Health ProfessionalsJanuary 13, 2014 · Drugs · Product safety
- Pantoprazole (2013-12-11)January 13, 2014 · Drugs · Product safety · Type III
- Diltiazem CD (2013-12-17)January 13, 2014 · Drugs · Product safety · Type III
- PolyLax (2013-10-16)January 13, 2014 · Drugs · Product safety · Type III
- Jevtana (cabazitaxel) - Potential for Medication Errors During Preparation Leading to Overdose - Notice to HospitalsJanuary 10, 2014 · Drugs · Dosage
- Jevtana (cabazitaxel) - Potential for Medication Errors During Preparation Leading to Overdose - For Health ProfessionalsJanuary 10, 2014 · Drugs · Dosage
- Jean Coutu Duo Stem Recall (2013-11-18)January 6, 2014 · Drugs · Product safety · Type II
- Solu-Medrol 1G solvent 8mL Act-O-Vial (2013-12-23)January 6, 2014 · Drugs · Product safety · Type III
- Clindamycin Injection SDZ (2013-12-23)January 6, 2014 · Drugs · Product safety · Type III
- CO Fluvoxamine (2013-12-24)January 6, 2014 · Drugs · Product safety · Type I
- Sublinox (zolpidem tartrate) - New Dosage Recommendations to Minimize Risk of Next-Day Impairment in Both Women and Men - For the PublicJanuary 3, 2014 · Drugs · Dosage
- Folic Acid Injection, USP, 5 mg/mL, 10 mLJanuary 3, 2014 · Drugs · Product safety · Type II
- Sublinox (zolpidem tartrate) - New Dosage Recommendations to Minimize Risk of Next-Day Impairment in Both Women and Men - For Health ProfessionalsJanuary 3, 2014 · Drugs · Dosage
- Methotrexate (2013-12-13)January 3, 2014 · Drugs · Product safety · Type I
- Teva-Galantamine ER (2013-12-12)January 3, 2014 · Drugs · Product safety · Type II
Other health products
- Safe Handling and Cooking of ShellfishDecember 15, 2014 · Other · Product safety
- Holiday Food SafetyDecember 10, 2014 · Other · Product safety
- Unpasteurized Fruit Juice and CiderOctober 15, 2014 · Other · Product safety
- Enjoying Leftover Food SafelyOctober 10, 2014 · Other · Product safety
- Food safety tips for ThanksgivingOctober 6, 2014 · Other · Product safety
- Home canning - prepare it safelyAugust 25, 2014 · Other · Product safety
- Food Safety Tips for Fresh ProduceJuly 7, 2014 · Other
- Summer Food SafetyJune 23, 2014 · Other
- Enjoying Leftover Food SafelyApril 15, 2014 · Other
- Reminding Canadians of Egg Safety this EasterApril 10, 2014 · Other
- Food Safety for People with Weakened Immune SystemsMarch 11, 2014 · Other
- Food Safety for Older AdultsFebruary 25, 2014 · Other
- Food safety for kids who are five and underFebruary 18, 2014 · Other
- Eating Well with Canada's Food GuideJanuary 27, 2014 · Other
Natural health products
- Additional products seized from two Calgary stores pose health risksDecember 31, 2014 · Natural health products · Unauthorized product - Product safety
- Forta for Men (2014-12-30)December 31, 2014 · Natural health products · Product safety · Type I
- Foreign Product Alerts: Slim Perfect Arm, Slim Perfect Legs, Lingzhi Cleansed Slim Tea, Trim-Fast Slimming Softgel, Sliming Diet By Pretty White, Lipo 8 Burn Slim, Best Line Suplemento Alimenticio Capsules, Slyn Both Green capsules, Mezo, and Mix Fru...December 30, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: Bo Ying compoundDecember 30, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: LX1December 30, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: JOINT-SOFT, KEBIGUTAIJIAONANG, and Pil Raja Urat AsliDecember 30, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: Zhansheng Weige Chaoyue Xilishi, Chong Cao Zhag Bian Bao, Night Man, MMC Sex Men capsules, O.M.G., Arize, and Herbal Vigor Quick FixDecember 30, 2014 · Natural health products · Undeclared substance
- "Forta for Men" sex enhancement product recalled; contains undeclared drugDecember 30, 2014 · Natural health products
- Herberex (2014-12-12)December 23, 2014 · Natural health products · Product safety · Type I
- "Hydro-Lean" weight loss product seized from two Calgary stores due to serious safety risksDecember 23, 2014 · Natural health products
- "Herberex" sex enhancement product recalled after Health Canada tests found hidden drug ingredientDecember 19, 2014 · Drugs - Natural health products · Undeclared substance
- Versel Lotion 2.5% (2014-12-10)December 12, 2014 · Natural health products · Product safety · Type III
- Jamp-Quinine (2014-11-21)December 12, 2014 · Natural health products · Product safety · Type II
- Megafood Daily Energy 52.5 g (2014-11-06)December 3, 2014 · Natural health products · Product safety · Type III
- Aristolochia clematitis (2014-11-05)December 3, 2014 · Natural health products · Product safety · Type I
- Zeolite Pure (2014-11-21)December 2, 2014 · Natural health products · Product safety · Type II
- Gra-MaxX Gold: Seized from "ShopForYou", Vancouver, B.C. due to serious safety risksNovember 7, 2014 · Natural health products
- Chlorophylle Menthe (2014-10-17)November 6, 2014 · Natural health products · Product safety · Type III
- Health Canada seizes dangerous health products from online retailerOctober 18, 2014 · Drugs - Natural health products
- Pascoflair (2014-08-21)September 15, 2014 · Natural health products · Product safety · Type III
- Foreign Product Alerts: Gold Vigra, Liu Bian Li, GoldReallas, Black Ant Strong, My Man His Enhancer 12 Pack, Top Man 3, Vigour 800, Dick's Hard Up, P-Boost, NatuRECT, 3 Hard Knights, Germany Niubian, and Alpha Male REDDES (or REDDIES), The Rock, Full...September 5, 2014 · Drugs - Natural health products · Undeclared substance
- Foreign Product Alerts: Sliming Diet, SlimExtra Herbal Capsules, 1 Day Diet, LYPOLYSIS II, La Jiao Shou Shen, B-Perfect, Diet Master, Super Slim, Slim Max, and Sport BurnerSeptember 5, 2014 · Drugs - Natural health products · Undeclared substance
- Foreign Product Alerts: JIN LONG Snakes Bones Rheumatic CapsulesSeptember 5, 2014 · Drugs - Natural health products · Undeclared substance
- FORMX (2014-07-17)August 12, 2014 · Natural health products · Product safety · Type II - Type III
- Evening Primrose Oil Capsule (2014-06-24)August 12, 2014 · Natural health products · Product safety · Type III
- Foreign Product Alerts: Sanovera Starter capsules, Yanhee Slim, Infinity, Asset Bee Pollen, Asset Bold, Slim Trim U, Natural Body Solution, and 3X Slimming Power capsuleAugust 11, 2014 · Natural health products
- Foreign Product Alerts: MV5 Days, S.W.A.G, Zhansheng Weige Cahoyue Xilishi tablets, Ying Dao Di capsules, Robust tabletsAugust 11, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: Shwasa Sanjeevani and Golden Dragon Linzi Dong Mai DanAugust 11, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: Herbal Health Jointcare, Herbal Health RU Special Cream, Herbal Health YI Special Cream, Herbal Health JI Special Cream, Herbal Health XIANG Special Cream, Herbal Health Backplus 500mg, and Herbal Health V+August 11, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: Powerful leg-slimming capsules, Pink grain herbal slimming capsules, and Night fat-burning slimming capsulesJuly 16, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: MME Naturally Maxman capsules, Blue Fantasy capsules, African Superman tablets, and MosKa - energy for adultsJuly 16, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: Bella Vi Insane Bee Pollen Capsules, Bella Vi BTrim Ultimate Boost, Bella Vi BTrim Max, Bella Vi Extreme AcceleratorJuly 16, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: Super Fat Burner capsules, Maxi Gold capsules, and Esmeralda softgelsJuly 16, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: Zi Xiu Tang Pollen capsule and Zi Xiu Tang Beauty Face and Figure capsuleJuly 16, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: [Wing Cheong Tong] Bak Feng Pill, [Yee On Tong] Bak Feng Pill, and Beijing Bak Feng PillJuly 16, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: Fruta Bio, Jianfeijindan Activity Girl, and LTD Japanese Chinese Formula pill for weight reductionJuly 10, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: Weekend Warrior and Lian Zhan Qi Tian capsulesJuly 10, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: Vitaccino Coffee, Collagen Slim, and SulamiJuly 10, 2014 · Natural health products · Undeclared substance
- Recall of unauthorized health product: "Cellfood"June 23, 2014 · Natural health products · Labelling
- Muro 128 5% Ointment (2014-06-02)June 18, 2014 · Natural health products · Product safety · Type II
- Foreign Product Alerts: Bali Mojo, Vimax, LOVher capsules, Erec-Bull, Best Whips, JINQIANGBUDOR Red Dragon, Super Hard tablets and CONTROL All Natural Sexual EnhancementJune 17, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: Phen Tabz, Asset Extreme, Asset Extreme Plus, Meizitang Citrus, Slimming Diet Berry Plus, Citrus Fit Gold, Hot Detox, Thinogenics, Tonic Life BP, Slimfast Capsules, Dr. Ming's Chinese Capsule, Magic Slim and Apple's Quick Impa...June 17, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: Pro ArthMax, Adipotrim XT and StemAliveJune 17, 2014 · Natural health products · Undeclared substance
- Equate Black Cohosh (2014-05-15)May 27, 2014 · Natural health products · Product safety · Type III
- RapidCuts Shredded Capsule (2014-05-22)May 22, 2014 · Natural health products · Product safety · Type II
- Unauthorized drug (Lite Fit USA) being sold in CanadaMay 16, 2014 · Natural health products · Unauthorized product
- "Thyroid Gland" no longer authorized for saleMay 13, 2014 · Natural health products
- Cold Assist Extra Strength (2014-04-24)May 9, 2014 · Natural health products · Product safety · Type III
- Cold Assist (2014-04-24)May 8, 2014 · Natural health products · Product safety · Type III
- Foreign Product Alerts: Blue StingerMay 7, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: Live Clinical 90 CapsMay 1, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: Instant SlimMay 1, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: OrtigaMay 1, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: Jack RabbitMay 1, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: Esbelin siloutte té, Esbelin siloutte Herbal Blend with L-Carnitine, Esbelder man, Esbelder fem, and Esbelder siloutteMay 1, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: 72 HP, Evil Root and Pro Power MaxApril 28, 2014 · Natural health products
- Foreign Product Alert: Dr. Larry's TranquilityApril 24, 2014 · Drugs - Natural health products · Undeclared substance
- Foreign Product Alerts: San Xiao Ping Tang Jin Qi Jiao NangApril 24, 2014 · Drugs - Natural health products · Undeclared substance
- Foreign Product Alerts: Volcano Male Enhancement Liquid, and Volcano Male Enhancement CapsulesApril 24, 2014 · Drugs - Natural health products · Undeclared substance
- Formule L1 and Détox Printemps-Automne Combination PackMarch 14, 2014 · Natural health products · Product safety · Type I
- Nicorette Lozenges/Nicorette Mini Lozenges (2014-02-24)March 14, 2014 · Natural health products · Product safety · Type III
- Cold Assist Recall (2013-12-02)February 19, 2014 · Natural health products · Product safety · Type II
- Foreign Product Alerts: Various sexual enhancement productsFebruary 7, 2014 · Natural health products · Undeclared substance
- Foreign Product Alert: MONTALIN Jamu Pegal Linu Dan Asam UratFebruary 7, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: BONJOUR, CURVY Pearl Beauty slimming orange juice, VTOX Trim Up, and V12 Fruit SlimmingFebruary 7, 2014 · Natural health products · Undeclared substance
- Foreign Product Alert: Lami CapsulesFebruary 7, 2014 · Natural health products · Undeclared substance
- Foreign Product Alerts: Bethel 30, Bethel Advance, Quick Thin, JaDera, Xiyouji Qingzhi, Extreme Body Slim, Paiyouji Plus, Fat Zero, Fruit & Plant Slimming, and Strawberry BalanceFebruary 7, 2014 · Natural health products · Undeclared substance
- Foreign Product Alert: Plexus Slim Accelerator capsules, and Plexus Slim Accelerator 3 Day Trial packFebruary 7, 2014 · Natural health products · Undeclared substance
- Hyper FX (2014-01-14)January 28, 2014 · Natural health products · Product safety · Type II
- Royal Jelly 1200mg (2014-01-03)January 13, 2014 · Natural health products · Product safety · Type I
- Factors Group of Nutritional Companies Inc Recall (2013-11-18)January 6, 2014 · Natural health products · Product safety · Type I
- Digestive Enzymes Recall (2013-10-18)January 6, 2014 · Natural health products · Product safety · Type I
- MegaFood Supplement Recall (2013-11-18)January 6, 2014 · Natural health products · Product safety · Type I
- Natural health product (Alive Vitamins - Royal Jelly 1200 mg) recalled due to contamination with the antibiotic chloramphenicolJanuary 3, 2014 · Natural health products · Contamination
- Women's Phytoestrogen Formula (2013-12-12)January 3, 2014 · Natural health products · Product safety · Type I
- Sequel Naturals Recall (2013-11-06)January 3, 2014 · Natural health products · Product safety · Type I
Medical devices
- Ruby Set V2 Tubing (2014-12-19)December 30, 2014 · Medical devices · Medical devices · Type III
- Heartstart MRx Defibrillator/Monitor (2014-12-16)December 30, 2014 · Medical devices · Medical devices · Type II
- Bond Universal Covertiles ( 2014-11-07)December 29, 2014 · Medical devices · Medical devices · Type III
- Phillips IntelliVue Information Centre (PIIC) IX (2014-12-17)December 29, 2014 · Medical devices · Medical devices · Type II
- Port-A-Cul Tubes (2012-12-01)December 29, 2014 · Medical devices · Type III
- iChem 10 SG Urine Chemistry Strips (2014-12-09)December 29, 2014 · Medical devices · Medical devices · Type III
- Monaco (2014-12-19)December 29, 2014 · Medical devices · Medical devices · Type II
- Immage Immunochamistry Systems Apolipoprotein A-1 (APA) and Beckman Coulter Clinical Chemistry Systems APO CAL (Apolipoprotein Calibrator) (2014-12-09)December 29, 2014 · Medical devices · Medical devices · Type III
- Focal Software CD (2014-12-19)December 29, 2014 · Medical devices · Medical devices · Type II
- Micro SSP Generic HLA Class I DNA Typing Trays (2014-11-26)December 29, 2014 · Medical devices · Medical devices · Type II
- QIAsymphony DSP Virus/Pathogen Midi Kit (2014-12-08)December 29, 2014 · Medical devices · Medical devices · Type II
- Guardian Real-Time Continuous Glucose Monitoring System (2014-12-03)December 23, 2014 · Medical devices · Medical devices · Type III
- Clear-Guard Midi (2014-12-11)December 23, 2014 · Medical devices · Medical devices · Type II
- 35X Proflexx Complete (2014-12-02)December 23, 2014 · Medical devices · Medical devices · Type II
- Persona TASP Shims and Persona Constrained TASP Shims (2014-12-16)December 23, 2014 · Medical devices · Medical devices · Type II
- Allura Xper FD10 (2014-12-09)December 23, 2014 · Medical devices · Medical devices · Type III
- VWR Pre-calibrated Microhematocrit Tubes with Heparin (2014-08-11)December 23, 2014 · Medical devices · Medical devices · Type III
- Brilliance CT Big Bore System-Main Unit and Ingenuity CT System (2014-12-10)December 23, 2014 · Medical devices · Medical devices · Type II
- Beckman Coulter AU,AU2700 and AU5400 Immunochemistry System Reagents (2014-12-08)December 23, 2014 · Medical devices · Medical devices · Type II
- Aequalis - Humeral Implant Broach (2014-12-08)December 23, 2014 · Medical devices · Medical devices · Type II
- Nemschoff Serenity Chair (2014-10-02)December 23, 2014 · Medical devices · Medical devices · Type II
- Luxor Lamp (2014-12-11)December 23, 2014 · Medical devices · Medical devices · Type II
- Proteus XR/a X-ray Imaging Systems (2014-12-11)December 18, 2014 · Medical devices · Medical devices · Type II
- Focus Dental X-ray System (2014-01-14)December 18, 2014 · Medical devices · Medical devices · Type II
- Thermo Scientific Reagent Grade Deionized Water (2014-09-24)December 18, 2014 · Medical devices · Medical devices · Type III
- HDI 5000 System (2014-12-03)December 18, 2014 · Medical devices · Medical devices · Type III
- Silane Refill (2014-11-20)December 18, 2014 · Medical devices · Medical devices · Type III
- Galileo NEO Automated Blood Bank System (2014-12-11)December 18, 2014 · Medical devices · Medical devices · Type II
- Brainscan Radiosurgery System-Software and iPlan RT Dose ( 2014-11-19)December 18, 2014 · Medical devices · Medical devices · Type II
- Liaison Aldosterone control sets (2014-12-05)December 18, 2014 · Medical devices · Medical devices · Type III
- cobas IT1000 Software (2014-12-11)December 18, 2014 · Medical devices · Medical devices · Type II
- INRatio Patient Self-Testing Monitoring System, INRatio PT Monitoring System (Professional Use) and INRatio Prothrombin Time/INR Strips (2014-12-09)December 18, 2014 · Medical devices · Medical devices · Type I
- Heartstart MRx Defibrillator/Monitor (2014-11-20)December 15, 2014 · Medical devices · Medical devices · Type II
- Minicap with Povidone-Iodine Solution (2014-12-01)December 15, 2014 · Medical devices · Medical devices · Type II
- Reamer and Glass Fiber Post Kit (2014-09-30)December 15, 2014 · Medical devices · Medical devices · Type II
- INNOVA E4 Washer-Disinfector (2014-12-02)December 15, 2014 · Medical devices · Medical devices · Type II
- ADVIA 1200 Chemistry System - Liquid Specific Protein Calibrator and ADVIA Chemistry System - Liquid Specific Protein (2014-11-06)December 15, 2014 · Medical devices · Medical devices · Type III
- Various Bronchial Double lumen Tube Sets (2014-11-21)December 15, 2014 · Medical devices · Medical devices · Type II
- Autogen ICD and CRT-D ( 2014-11-17)December 15, 2014 · Medical devices · Medical devices · Type II
- Heartstart XL,MRx,XL+ Defibrillator/Monitor and ECG Out Sync Cable (2014-11-20)December 15, 2014 · Medical devices · Medical devices · Type II
- Imbibe Bone Marrow Aspiration Needles (2014-12-05)December 15, 2014 · Medical devices · Medical devices · Type II
- Atricure Cryoice Cryo-Ablation Probe (2014-11-27)December 15, 2014 · Medical devices · Medical devices · Type II
- DRX Revolution Mobile X-ray System (2014-11-24)December 11, 2014 · Medical devices · Medical devices · Type II
- COULTER 5C Cell Control, Abnormal II (2014-12-01)December 11, 2014 · Medical devices · Medical devices · Type III
- Vitros Immunodiagnostic, Integrated and Chemistry System (2014-11-20)December 11, 2014 · Medical devices · Medical devices · Type II
- Ambient HipVac50 wand (2014-11-07)December 11, 2014 · Medical devices · Medical devices · Type II
- Surveryor Patient Monitors (2014-10-06)December 11, 2014 · Medical devices · Medical devices · Type III
- TORIC UV Blocking Ocufilcon D Soft Contact Lens (2014-10-24)December 11, 2014 · Medical devices · Medical devices · Type III
- Herculite Ultra Refill Syringe and Herculite Ultra Unidose Refill (2014-07-23)December 11, 2014 · Medical devices · Medical devices · Type III
- Tegaderm High Performance Foam Adhesive Dressing (2014-12-02)December 11, 2014 · Medical devices · Medical devices · Type III
- All Flow Pulmonary Function Filters (2014-11-19)December 11, 2014 · Medical devices · Medical devices · Type III
- Heartstart MRx Defibrillator/Monitor (2014-11-17)December 11, 2014 · Medical devices · Medical devices · Type II
- cobas IT Middleware (2014-11-24)December 11, 2014 · Medical devices · Medical devices · Type II
- Laparoscopic Electric Morcellators - Update on the Risk of Spread of Unsuspected Uterine Cancer - Notice to HospitalsDecember 10, 2014 · Medical devices · Product safety
- cobas IT middleware (2014-11-25)December 5, 2014 · Medical devices · Medical devices · Type II
- Cyberknife Robotic Radio Surgery System - Iris Collimator (2014-10-29)December 5, 2014 · Medical devices · Medical devices · Type II
- Peritoneal Dialysis(PD) Swan Neck Catheters (2014-11-10)December 5, 2014 · Medical devices · Medical devices · Type III
- ONE-LINK Non-DEHP Y-Type, ONE-LINK Non-DEHP and Bonded ONE-LINK Non-DEHP Microbore Sets (2014-11-24)December 5, 2014 · Medical devices · Medical devices · Type II
- OSSEOTITE NT Implant Dental Implant, OSSEOTITE 2 Certain Implant and T3 Tapered Implant (2014-11-10)December 5, 2014 · Medical devices · Medical devices · Type II
- Persona Tibial Articular Surface Insert (2014-11-27)December 5, 2014 · Medical devices · Medical devices · Type II
- KimVent Microcuff Subglottic Suctioning Endotracheal Tube (2014-11-21)December 5, 2014 · Medical devices · Medical devices · Type II
- Sysmex UF-100 Instrument Manager Software (2013-11-06)December 5, 2014 · Medical devices · Medical devices · Type II
- Heartstart MRx Defibrillator/Monitor (2014-11-17)December 4, 2014 · Medical devices · Medical devices · Type II
- Trilogy Bone Screws, 6.5mm x 35mm & 25mm (2014-11-26)December 4, 2014 · Medical devices · Medical devices · Type II
- Heartstart MRx Defibrillator/Monitor (2014-11-17)December 4, 2014 · Medical devices · Medical devices · Type II
- Protektor IOM and Protektor 32 System (2014-10-29)November 28, 2014 · Medical devices · Medical devices · Type II
- Outgoing XML Results Interface (2014-11-17)November 28, 2014 · Medical devices · Medical devices · Type III
- Adult Radiotransparent Electrode, Pediatric Radiotranslucent Electrode and Mini Pediatric Radiotranslucent Electrode (2014-11-18)November 28, 2014 · Medical devices · Medical devices · Type I
- Laparoscopic Manual Instruments and Accessories (2014-11-21)November 28, 2014 · Medical devices · Medical devices · Type II
- HEALON EndoCoat (2014-11-17)November 28, 2014 · Medical devices · Medical devices · Type II
- SenTec Digital Monitor System - Monitor (2014-11-20)November 28, 2014 · Medical devices · Medical devices · Type II
- Hudson RCI Sheridan/CF Cuffed Tracheal Tube (2014-11-12)November 28, 2014 · Medical devices · Medical devices · Type II
- Infant Radiant Warmers (2014-11-18)November 28, 2014 · Medical devices · Medical devices · Type I
- HemosIL PT-Fibrinogen HS PLUS (2014-11-21)November 28, 2014 · Medical devices · Medical devices · Type II
- Syngo Imaging XS-VA60B, Syngo Imaging XS-VA70A and Syngo.Plaza (2014-11-19)November 28, 2014 · Medical devices · Medical devices · Type II
- Information Update - Multiple distributors selling unlicensed Home-Use HIV Test Kits via amazon.caNovember 28, 2014 · Medical devices · Unauthorized product
- DC Bead M1 Embolic Drug-Eluting Bead (2014-11-21)November 28, 2014 · Medical devices · Medical devices · Type II
- Paradigm Sure-T, Silhouette, Comfort Short, Comfort Kit, Contact Detach, Accu-Check Tender I and II Infusion Sets (2014-11-03)November 27, 2014 · Medical devices · Medical devices · Type II
- Dimension Vista System - MYO Calibrator (2014-11-14)November 26, 2014 · Medical devices · Medical devices · Type III
- Auto 2D Quantification Software, Auto Cardiac Motion QUantification software and Q-Station (2014-11-06)November 26, 2014 · Medical devices · Medical devices · Type II
- Sublimator Medical Kit (2014-10-29)November 26, 2014 · Medical devices · Medical devices · Type II
- CT TAVI Planning Application in Intellispace Portal V.6 (2014-11-09)November 26, 2014 · Medical devices · Medical devices · Type II
- Superstat Modified Collagen Hemostat (2012-11-13)November 26, 2014 · Medical devices · Type II
- Dialog+ SW 9.XX Two Pump Machines (incl. HDF online) (2014-11-17)November 26, 2014 · Medical devices · Medical devices · Type II
- ABL800 Flex System-CREA Electrode and Membrane (2014-10-29)November 26, 2014 · Medical devices · Medical devices · Type II
- ABX Pentra 400 Clinical Chemistry Systems (2014-09-26)November 26, 2014 · Medical devices · Medical devices · Type III
- Various Dimension Chemistry, Clinical Chemistry, EXL and XP System Products - I (2014-10-10)November 24, 2014 · Medical devices · Medical devices · Type III
- Various Dimension Chemistry, Clinical Chemistry, EXL and XP System Products - III (2014-10-10)November 24, 2014 · Medical devices · Medical devices · Type III
- Various Dimension Chemistry, Clinical Chemistry, EXL and XP System Products - IV (2014-10-10)November 24, 2014 · Medical devices · Medical devices · Type III
- Various Dimension Chemistry, Clinical Chemistry, EXL and XP System Products - II (2014-10-10)November 24, 2014 · Medical devices · Medical devices · Type III
- neoBLUE LED Phototherapy (neoBLUE 2 with replacement board) (2014-11-05)November 21, 2014 · Medical devices · Medical devices · Type II
- Non Absorbable Silky II Polydek Suture (2014-03-24)November 21, 2014 · Medical devices · Medical devices · Type II
- LeoniPlus and LeoniPlus with HFO (2014-11-05)November 21, 2014 · Medical devices · Medical devices · Type II
- Biograph mCT Flow-4R (2014-07-11)November 21, 2014 · Medical devices · Medical devices · Type II
- Attune Fixed Bearing Tibial and Femoral Component Impactor, Attune Rotating Platform Tibial Impact, and Attune Intuition Impaction Handle (2014-11-11)November 21, 2014 · Medical devices · Medical devices · Type II
- Promogran Protease Modulating Matrix (2014-02-07)November 21, 2014 · Medical devices · Medical devices · Type III
- eFilm Workstation 4.0 and eFilm Workstation 4.0.1 (2014-08-28)November 21, 2014 · Medical devices · Medical devices · Type III
- Drill Set, Single Patient Use, Sterile (2014-10-29)November 21, 2014 · Medical devices · Medical devices · Type III
- Urgent safety information for insulin pump usersNovember 21, 2014 · Medical devices
- Brightview XCT Imaging System - Tilt System (2014-11-07)November 21, 2014 · Medical devices · Medical devices · Type III
- Polyflux Revaclear Dialyzers (2014-11-12)November 21, 2014 · Medical devices · Medical devices · Type II
- Clinitek Novus Automated Urine Chemistry Analyzer (with and without rack handler) (2014-11-10)November 20, 2014 · Medical devices · Medical devices · Type III
- TB Potassium Permanganate (2014-10-29)November 20, 2014 · Drugs · Medical devices · Type III
- Monarc + Subfacial and C Subfacial Hammock, and AMS Advance and Advance XP Male Sling System (2014-10-20)November 20, 2014 · Medical devices · Medical devices · Type II
- Shigella dysenteriae Polyvalent (2014-08-15)November 20, 2014 · Medical devices · Medical devices · Type III
- Brightview Gamma Camera Systems (2014-11-07)November 20, 2014 · Medical devices · Medical devices · Type II
- TPHA Screen (2014-11-12)November 20, 2014 · Medical devices · Medical devices · Type III
- Various Dimension Vista Flex Reagent Cartridges (2014-11-12)November 20, 2014 · Medical devices · Medical devices · Type III
- Titan T 5K low-speed motor (2014-09-08)November 20, 2014 · Medical devices · Medical devices · Type III
- HemoCue Glucose 201 Microcuvette (2014-11-04)November 20, 2014 · Medical devices · Medical devices · Type II
- AFB III Staining Kit (2014-11-03)November 20, 2014 · Medical devices · Medical devices · Type II
- Fisher Healthcare Protocol 10% Buffered Formalin-Filled Containers and Thermo Scientific Richard Allan Scientific Specimen Transportation System (2014-09-19)November 18, 2014 · Medical devices · Medical devices · Type II
- Pak, Ultrasound Fluidics Management System (2014-11-04)November 18, 2014 · Medical devices · Medical devices · Type I
- Mammomat Inspiration System - Main Unit (2014-10-29)November 18, 2014 · Medical devices · Medical devices · Type III
- Zimmer PSI Knee-Nexgen PRI Jigs & Offset Tibia Rotation Right (2014-11-03)November 18, 2014 · Medical devices · Medical devices · Type II
- Syngo Imaging XS VA70A (2014-11-03)November 18, 2014 · Medical devices · Medical devices · Type III
- Physiologic DiGiPro Thermometer (2014-10-30)November 18, 2014 · Medical devices · Medical devices · Type II
- Mosaiq (2014-11-07)November 18, 2014 · Medical devices · Medical devices · Type II
- Dimension Vista 1500 and 500 Lab Systems (2014-11-06)November 18, 2014 · Medical devices · Medical devices · Type III
- Kool-Kit Neonate (2014-11-03)November 7, 2014 · Medical devices · Medical devices · Type III
- Various Devices of Mandible External Fixator System (2014-10-09)November 7, 2014 · Medical devices · Medical devices · Type II
- Titan Surgical Table (2014-10-17)November 7, 2014 · Medical devices · Medical devices · Type II
- Microscan Rapid Neg Urine Combo Panel (2014-10-22)November 7, 2014 · Medical devices · Medical devices · Type II
- ADVIA Chemistry Systems- Direct HDL Cholesterol( D-HDL) Assay (2014-10-24)November 7, 2014 · Health products · Medical devices · Type III
- 700 CX/ CXM Inflatable Penile Prosthesis (2014-10-22)November 7, 2014 · Health products · Medical devices · Type III
- X-Ray Film SG-Regular Green (2014-10-09)November 7, 2014 · Health products · Medical devices · Type III
- Thermocool Smart Touch Catheter (Uni-Directional and Bi-Directional) (2014-10-22)November 7, 2014 · Health products · Medical devices · Type II
- Comp Position Positioning Chair (2014-05-07)November 7, 2014 · Health products · Medical devices · Type II
- Various Anspach devices (2014-05-08)November 7, 2014 · Medical devices · Medical devices · Type II
- Radius Loop Electrodes (P/N R2010) (2014-10-28)November 4, 2014 · Health products · Medical devices · Type III
- Mindray Invasive Blood Pressure Module used with DPM 6 Monitor and Pressure Module used with DPM 7 Monitor (2014-10-04)November 4, 2014 · Health products · Medical devices · Type I
- Profile-II A (2014-10-20)November 4, 2014 · Health products · Medical devices · Type II
- Mas Cardioimmune XL, Level 1, 2, 3 (2014-10-22)November 4, 2014 · Health products · Medical devices · Type III
- Optiflux Hemodialyzers and Optiflux Capillary Dialyzer (2014-02-13)November 4, 2014 · Health products · Medical devices · Type II
- Attune Intuition Distal Femoral Jig (2014-10-17)November 4, 2014 · Health products · Medical devices · Type II
- Pregnancy Test Biomedic (2013-02-11)November 4, 2014 · Medical devices · Medical devices · Type II
- 10% Buffered Neutral Formalin (2014-06-11)November 4, 2014 · Medical devices · Medical devices · Type III
- Prime Care Transcend Mattress, Advanced Mattress and Prime Plus Transcend High Capacity Mattress (2014-08-11)November 4, 2014 · Medical devices · Medical devices · Type III
- Compass System-Main Software Application (2014-09-25)November 4, 2014 · Medical devices · Medical devices · Type II
- CellPack DST (2014-07-14)October 29, 2014 · Health products · Medical devices · Type III
- Bone Level 4.1mm RC, Slactive 8mm TIZR, Loxim Implant (2014-09-24)October 29, 2014 · Health products · Medical devices · Type II
- Infinite 200 PRO,Infinite M 1000 PRO and Sunrise (2014-10-10)October 29, 2014 · Medical devices · Medical devices · Type II
- Nexgen TM Tibial Impactor Pad (2014-10-17)October 29, 2014 · Medical devices · Medical devices · Type III
- Heart Vent Catheter, Atrial and Ventricular (2014-10-17)October 29, 2014 · Medical devices · Medical devices · Type II
- Coulter HMX Hematology Analyzers and Coulter IH 500 Series System (2014-10-20)October 29, 2014 · Medical devices · Medical devices · Type III
- Tampa Catheter (2014-06-02)October 29, 2014 · Medical devices · Medical devices · Type II
- AMS Advance SP Male Sling System (2014-07-28)October 29, 2014 · Medical devices · Medical devices · Type II
- Joerns Healthcare EasyCare Bed (2014-10-07)October 29, 2014 · Medical devices · Medical devices · Type II
- Maxillofacial Pack (2014-10-15)October 29, 2014 · Medical devices · Medical devices · Type III
- Oxoid Legionella BCYE Growth Supplement (2014-10-14)October 27, 2014 · Medical devices · Medical devices · Type III
- MicroVue Bb Plus EIA (2014-10-17)October 27, 2014 · Medical devices · Medical devices · Type III
- Embryoscope ES-D (2014-04-24)October 27, 2014 · Medical devices · Medical devices · Type III
- Euro Lift 2005 ND (2014-09-29)October 27, 2014 · Medical devices · Medical devices · Type I
- Zimmer Universal Power System Handpiece (2014-10-21)October 27, 2014 · Medical devices · Medical devices · Type II
- Dimension XP and XP System-Phenytoin (PTN) Assay and Dimension Clinical Chemistry System-Phenytoin (2014-09-22)October 27, 2014 · Medical devices · Medical devices · Type II
- Accu-Chek Spirit Combo Insulin Infusion Pump (2014-10-07)October 27, 2014 · Medical devices · Medical devices · Type II
- BD Insyte Autoguard (2014-10-10)October 27, 2014 · Medical devices · Medical devices · Type III
- Disposable Falope Ring Band Applicator Kit (2014-10-09)October 27, 2014 · Medical devices · Medical devices · Type II
- Transcranial direct current stimulation and SmartStim TDCS (2014-08-18)October 27, 2014 · Medical devices · Medical devices · Type III
- Persona Articular Surface Inserter (2014-10-07)October 22, 2014 · Medical devices · Medical devices · Type III
- Symbia T Gamma Camera/CT Scanner and Symbia S Photon Emission Computed Tomography System (SPECT) (2014-10-14)October 22, 2014 · Medical devices · Medical devices · Type II
- Various Advia Centaur System (2014-10-15)October 22, 2014 · Medical devices · Medical devices · Type III
- Cadwell P/N 229038-000 Medical Power Supply (2014-09-26)October 22, 2014 · Medical devices · Medical devices · Type III
- Statspin Cytofuge 2 Centrifuge (2014-09-25)October 22, 2014 · Medical devices · Medical devices · Type III
- Elite XPL (Pulsed Light) Handpiece (2014-10-08)October 22, 2014 · Medical devices · Medical devices · Type II
- Steris 5085 and 5085SRT Surgical Table (2014-10-13)October 22, 2014 · Medical devices · Medical devices · Type II
- Advia Centaur CP and XP System-B-type Natriuretic Peptide (BNP) assay and Advia Centaur System-B-type Natriuretic Peptide (BNP) assay (2014-10-08)October 22, 2014 · Medical devices · Medical devices · Type III
- Health Canada puts measures in place for medically necessary products affected by import restriction from 3 facilities in IndiaOctober 17, 2014 · Medical devices
- IntelliVue MP5 and MP5SC Patient Monitor System and IntelliVue Patient Monitor MP5T (2014-09-24)October 14, 2014 · Medical devices · Medical devices · Type II
- Zoll Pro-Padz Sterile Multifunction Electrodes (2014-09-19)October 14, 2014 · Medical devices · Medical devices · Type II
- Prime Care Bed PCB900 (2014-09-25)October 14, 2014 · Medical devices · Medical devices · Type II
- Test Tube Heater Power Supply Component (2014-09-11)October 14, 2014 · Medical devices · Medical devices · Type III
- Radiolucent Bone Lever with Double Tip (2014-10-06)October 14, 2014 · Medical devices · Medical devices · Type II
- Tapered Screw-Vent Implant (2014-10-09)October 14, 2014 · Medical devices · Medical devices · Type III
- Digital Diagnost (2014-09-25)October 14, 2014 · Medical devices · Medical devices · Type III
- Puritan Bennett 980 Series Ventilator (2014-10-06)October 14, 2014 · Medical devices · Medical devices
- 2008T Hemodialysis System CDX (2012-04-16)October 14, 2014 · Medical devices · Type III
- G.O.L.F.F.-(Anti-Fog Solution for Endoscopes) (2014-09-29)October 14, 2014 · Medical devices · Medical devices · Type II
- Hudson RCI Nebulizer Adaptor (2014-09-26)October 14, 2014 · Medical devices · Medical devices · Type II
- ABX PENTRA Magnesium RTU (2014-09-26)October 10, 2014 · Medical devices · Medical devices · Type III
- Hudson RCI Pediatric Anesthesia Breathing Circuits (2014-09-15)October 10, 2014 · Medical devices · Medical devices · Type II
- N Latex B2 Microglobulin (2014-10-01)October 10, 2014 · Medical devices · Medical devices · Type III
- Leksell Gamma Knife Perfexion (2014-10-06)October 10, 2014 · Medical devices · Medical devices · Type II
- SAM Junctional Tourniquet, 2 Target Compression Devices (1 with extender), Hand Pump, Auxiliary Strap (2014-09-18)October 10, 2014 · Medical devices · Medical devices · Type II
- Statspin Cytofuge 2 Centrifuge (2014-09-25)October 10, 2014 · Medical devices · Medical devices · Type III
- Dimension Vista System - Hemoglobin A1c (HbA1c), Dimension EXL system - Hemoglobin A1c (Hb1c),Dimension Xpand system - Hemoglobin A1c (Hb1c) and Dimension Cinical Chemistry System - Hemoglobin a (2014-09-24)October 10, 2014 · Medical devices · Medical devices · Type III
- OR Table ORT300 (2014-09-25)October 10, 2014 · Medical devices · Medical devices · Type III
- HeliTape Absorbable Collagen Wound Dresssing andHeliPLUG Absorbable Collagen Wound Dressing (2013-06-03)October 10, 2014 · Medical devices · Medical devices · Type II
- Cognis CRT-D HE, CRT-D and Teligen ICD (VR_HE DF1), (DR_HE IS-1) (2014-09-21)October 9, 2014 · Medical devices · Medical devices · Type II
- Advia Centaur, Advia Centaur CP and XP System (2014-09-29)October 9, 2014 · Medical devices · Medical devices · Type III
- UniCel DxC 600I Synchron Access Clinical Analyzer and Access 2 Immunoassay Systems (2014-09-28)October 9, 2014 · Medical devices · Medical devices · Type II
- UniCel DxI 600, DxI 800 Access Immunoassay Systems and UniCel DxC 880I, DxC 660I, DxC 680I, DxC 860I Synchron Access Clinical Systems (2014-08-18)October 9, 2014 · Medical devices · Medical devices · Type II
- Infusor, Intermate (2014-09-26)October 9, 2014 · Medical devices · Medical devices · Type II
- Trident Acetabular System Hemispherical Surgical Protocol and Trident Product Reference Guide (2014-09-22)October 9, 2014 · Medical devices · Medical devices · Type II
- Delfia Xpress 6000 Immunoanalyzer System - free HCG B assay (2014-09-22)October 9, 2014 · Medical devices · Medical devices · Type II
- Millenium VG Variable Geometry Dual Detector Camera-Hawkeye, Hawkeye 4, Infinia Dual Detector Gamma Camera, Discovery NM/CT 670 and NM 630 System (2014-09-25)October 9, 2014 · Medical devices · Medical devices · Type II
- Vitros 5600 Integrated Systems (2014-09-30)October 9, 2014 · Medical devices · Medical devices · Type III
- Clinitek Status System-Urine Chemistry Analyzer (2014-09-24)October 9, 2014 · Medical devices · Medical devices · Type II
- Stryker Smartlife - Small and Large Aseptic Housing (2014-09-30)October 9, 2014 · Medical devices · Medical devices · Type II
- Valve Tubing 841-797 for ABL90 Flex Analyzer (2014-09-11)October 9, 2014 · Medical devices · Medical devices · Type II
- Artis Zee Multi-Purpose and Artis Zee Biplane (2014-09-23)October 2, 2014 · Medical devices · Medical devices · Type II
- Progeny Vantage Panoramic X-Ray System-Cephalometric and Ceph Sensor (2014-09-19)October 2, 2014 · Medical devices · Medical devices · Type II
- Immulite System - Cortisol Assay (2014-09-24)October 2, 2014 · Medical devices · Medical devices · Type III
- Cell-Chex (2014-09-15)October 2, 2014 · Medical devices · Medical devices · Type III
- TRX Vertical Positioner (2014-08-18)October 2, 2014 · Medical devices · Medical devices · Type II
- Acrysof Cachet Phakic Lens (2014-09-19)October 2, 2014 · Medical devices · Medical devices · Type II
- Digital Inclinometer (2014-09-24)October 2, 2014 · Medical devices · Medical devices · Type III
- Abdominal Stent Graft System-Ovation Prime (2014-09-19)October 2, 2014 · Medical devices · Medical devices · Type II
- Raystation (2014-09-17)October 2, 2014 · Medical devices · Medical devices · Type II
- Esaote PA230E Transducer used with Esaote MyLab Systems- MyLab40 Ultrasound System Phased Array Probes and PA230E Variable Band Phased Array (2014-08-25)October 2, 2014 · Health products · Medical devices · Type II
- Proclear Toric (Omafilcon) Soft Contact Lens (2014-09-15)October 1, 2014 · Medical devices · Medical devices · Type III
- Stryker Air Pump (2014-08-21)October 1, 2014 · Medical devices · Medical devices · Type III
- Advia Centaur System, XP and CP - HBC Total Assay (2014-09-17)October 1, 2014 · Medical devices · Medical devices · Type III
- Multidiagnost Eleva - Flat Detector - Image Detector, Allura XPER FD10/10 - Main Unit,Allura XPER FD20/20-Main Unit,Allura XPER FD10 and Allura XPER FD20 System - Main Unit (2014-09-11)October 1, 2014 · Medical devices · Medical devices · Type II
- Vitek MS Plus (2014-09-04)October 1, 2014 · Medical devices · Medical devices · Type II
- Zenith Slide W-I-D-E Long Term Care Bed (Models 9000 and 7000) (2014-07-28)October 1, 2014 · Medical devices · Medical devices · Type III
- Premise Universal Restorative Body Syringe A2 and Premise Unidose Shade A2 (2014-07-14)October 1, 2014 · Medical devices · Medical devices · Type III
- Mammomat Inspiration Mammography System with Stereostatic/Biopsy Device (2014-09-22)October 1, 2014 · Medical devices · Medical devices · Type II
- Glucose Hexokinase (Liquid) Reagent (2014-04-07)October 1, 2014 · Medical devices · Medical devices · Type III
- Impulse Elite Oxygen Conserving Device (2014-09-03)October 1, 2014 · Medical devices · Medical devices · Type II
- SS Retractabed (2014-05-01)September 26, 2014 · Medical devices · Medical devices · Type II
- Bionector (2014-08-28)September 26, 2014 · Medical devices · Medical devices · Type II
- Artis Zeego Multi-Axis (2014-09-22)September 26, 2014 · Medical devices · Medical devices · Type II
- Kendall 1010P and Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes (2014-09-17)September 26, 2014 · Medical devices · Medical devices · Type I
- Cascade Pro-ES-IX Stimulator (2013-05-31)September 26, 2014 · Medical devices · Medical devices · Type II
- Intravia Container 150ml Capacity (2014-09-17)September 26, 2014 · Medical devices · Medical devices · Type II
- Trima Accel Automated Blood Collection System (2014-09-15)September 26, 2014 · Medical devices · Medical devices · Type II
- Babytherm 8000 LDR Warming Bed and Babytherm 8004/8010 (2014-08-31)September 26, 2014 · Medical devices · Medical devices · Type II
- OffRoad Re-entry Catheter System (2014-09-11)September 26, 2014 · Medical devices · Medical devices · Type III
- Free Radical Test Kit, Adrenal Function Urine Test, Sulkowitch Urine (Calcium) Test Kit, Osumex 10P Urine Analysis and pH Indicator Sticks (2014-05-15)September 26, 2014 · Medical devices · Medical devices · Type II
- Ultrafilter U9000 (2014-08-08)September 25, 2014 · Medical devices · Medical devices · Type II
- Aeroneb Pro AC/DC Adapter and Aeroneb Pro X Controller (2014-09-02)September 25, 2014 · Medical devices · Medical devices · Type II
- EDS 3 CSF External Drainage - With and Without Catheter (2014-09-16)September 25, 2014 · Medical devices · Medical devices · Type I
- Isothermal Custom Infant and AirLife Isothermal Neonate Respiratory Breathing Circuit (2014-07-31)September 25, 2014 · Medical devices · Medical devices · Type II
- Accu-Chek Rapid-D Infusion Set (2014-09-17)September 25, 2014 · Medical devices · Medical devices · Type III
- Titan T 5K low-speed motor (2014-09-08)September 25, 2014 · Medical devices · Medical devices · Type III
- Coulter DXH Diluent (2014-08-25)September 25, 2014 · Medical devices · Medical devices · Type II
- GenoType MTBDR plus (2014-09-04)September 25, 2014 · Medical devices · Medical devices · Type II
- Esaote PA230E Transducer used with Esaote MyLab Systems - MyLab 30CV Ultrasound, MyLab 50X Vision, MyLab 25 Ultrasound, MyLab 50CV Ultrasound, MyLab 30 Gold and Phased Array Probes (2014-08-25)September 25, 2014 · Medical devices · Medical devices · Type II
- Trak Back II Disposable Pullback Device (2014-08-19)September 25, 2014 · Medical devices · Medical devices · Type II
- Gas/Water Feeding Valves (2014-07-14)September 24, 2014 · Medical devices · Medical devices · Type I
- PSM Software (2014-08-13)September 24, 2014 · Medical devices · Medical devices · Type II
- Advia Centaur and Centaur XP System Instruments (2014-08-20)September 24, 2014 · Medical devices · Medical devices · Type II
- Ultraview SL2600,SL Compact Monitor and SL Bedside/Central Monitor (2014-09-18)September 22, 2014 · Medical devices · Medical devices · Type II
- Nelaton Whistle Tip, Robinson and Tiemann Catheter (2014-09-17)September 22, 2014 · Medical devices · Medical devices · Type II
- Architect I System - Total T3 Assay (2014-09-15)September 22, 2014 · Medical devices · Medical devices · Type II
- Tegaderm HP Transparent Film Dressing (2014-09-09)September 22, 2014 · Medical devices · Medical devices · Type III
- Radiomat B+ NIF 8 x 10 and SG 14 x 17 NIF (2014-07-16)September 22, 2014 · Medical devices · Medical devices · Type III
- Precision 500D X-ray imaging system (2014-09-12)September 22, 2014 · Medical devices · Medical devices · Type II
- Vitros 5600 and 4600 Integrated System (2014-09-09)September 22, 2014 · Medical devices · Medical devices · Type II
- Rota-strip Test Kit (2014-08-25)September 22, 2014 · Medical devices · Medical devices · Type III
- Scorpio NRG Knee System - Cruciate Retaining Femoral Component with Lugs (2014-08-22)September 22, 2014 · Medical devices · Medical devices · Type II
- CPR Shield (2014-06-20)September 22, 2014 · Medical devices · Medical devices · Type II
- Additional information on Mylan Pharmaceuticals nitroglycerin spray recallSeptember 21, 2014 · Drugs - Medical devices · Dosage - Product safety
- Mylan Pharmaceuticals recalling nitroglycerin spray due to defective pumpSeptember 20, 2014 · Medical devices
- Biograh PET/CT System (2014-06-20)September 16, 2014 · Medical devices · Medical devices · Type III
- Disposable gloves (2014-09-10)September 16, 2014 · Medical devices · Medical devices · Type III
- Allset Gold DPB1 High Resolution SSP Kit, DPB1 SSP UniTray 12 Tests and DPB1 SSP UniTray With Taq 12 Tests (2014-08-14)September 16, 2014 · Medical devices · Medical devices · Type II
- Bekman Coulter AU Immunochemistry System-AU480 (2013-09-03)September 16, 2014 · Medical devices · Medical devices · Type III
- Persona Knee System - Female Hex Screw (2014-09-08)September 16, 2014 · Medical devices · Medical devices · Type II
- ACROBAT V Vacuum Off-Pump System (2014-08-18)September 16, 2014 · Medical devices · Medical devices · Type II
- Vectra System Titanium (Ti) Plate Four Level (2014-09-05)September 16, 2014 · Medical devices · Medical devices · Type II
- SwitchPoint Infinity 3 Control System (2014-09-11)September 16, 2014 · Medical devices · Medical devices · Type III
- Presource Kit PE30TAHRA (Kit, Tonsils and Adenoids) (2014-08-06)September 16, 2014 · Medical devices · Medical devices · Type I
- Epics XL/MCL Analyzer, Cytomics FC 500 Flow Cytometer,Navios Lasers and FP1000 Cell Preparation System (2013-10-24)September 11, 2014 · Medical devices · Medical devices · Type III
- Mckesson Cardiology Hemo (2014-08-27)September 11, 2014 · Medical devices · Medical devices · Type II
- Outgoing XML Results Interface (2014-08-27)September 11, 2014 · Medical devices · Medical devices · Type III
- Ysio Radiography X-ray System (2014-09-02)September 11, 2014 · Medical devices · Medical devices · Type III
- 4D Integrated Treatment Console (2014-08-18)September 11, 2014 · Medical devices · Medical devices · Type II
- Infrared Coagulation System (IRC 2100) (2014-09-10)September 11, 2014 · Medical devices · Medical devices · Type II
- Spectrum Infusion Pump with Master Drug Library (2014-08-18)September 11, 2014 · Medical devices · Medical devices · Type I
- Rapidpoint 405 System - Analyzer (2014-09-03)September 11, 2014 · Medical devices · Medical devices · Type III
- Phased Array Transducer (2014-08-21)September 11, 2014 · Medical devices · Medical devices · Type II
- Salto Talaris Tibial Impactor (2014-08-11)September 11, 2014 · Medical devices · Medical devices · Type III
- Puritan Bennett 840 Ventilator System - Main Unit (2014-09-03)September 9, 2014 · Medical devices · Medical devices · Type II
- Dualok Breast Lesion Localization Wire (2014-09-03)September 9, 2014 · Medical devices · Medical devices · Type II
- Patient Data Module (2014-08-27)September 9, 2014 · Medical devices · Medical devices · Type II
- Standard Offset Cup Impactors (2014-03-28)September 9, 2014 · Medical devices · Medical devices · Type II
- Arctic Sun Temp Management System, 2000 and 5000 (2014-08-28)September 9, 2014 · Medical devices · Medical devices · Type II
- Galileo Echo Immunohaematology (2014-08-27)September 9, 2014 · Medical devices · Medical devices · Type II
- BD EpiCenterTM v6.20A (2014-08-19)September 9, 2014 · Medical devices · Medical devices · Type III
- Abbott m2000 system - m2000sp and m24sp Instrument (2014-08-13)September 9, 2014 · Medical devices · Medical devices · Type III
- Aquilion ONE System - Software (2014-08-12)September 9, 2014 · Medical devices · Medical devices · Type II
- STA - Liquid Anti Xa (2014-07-28)September 3, 2014 · Medical devices · Medical devices · Type III
- Precision Flow and Nitric Oxide Ready - Disposable Patient Circuit (2014-08-13)September 3, 2014 · Medical devices · Medical devices · Type II
- Eclipse Probe Cover (2014-08-20)September 3, 2014 · Medical devices · Medical devices · Type III
- Ellipse VR and Ellipse DR (2014-08-20)September 3, 2014 · Medical devices · Medical devices · Type II
- Hospira Receptal Liners (2013-09-12)September 3, 2014 · Medical devices · Medical devices · Type II
- Lambda Cell Trays (LCT) (2014-01-27)September 3, 2014 · Medical devices · Medical devices · Type III
- Accu-chek Inform II + RF Meter (2014-08-25)September 3, 2014 · Medical devices · Medical devices · Type III
- Fresenius 2008K and 2008T Hemodialysis System (2014-05-07)September 3, 2014 · Medical devices · Medical devices · Type III
- Mobilediagnost WDR (2014-08-20)September 3, 2014 · Medical devices · Medical devices · Type II
- Expert DC Dental X-ray (2014-08-22)September 3, 2014 · Medical devices · Medical devices · Type II
- Axiom Luminos DRF System-Main Unit (2014-08-12)August 28, 2014 · Medical devices · Medical devices · Type II
- Redcord Powergrip, Strap, Wide Sling, Narrow Sling, Split Sling and Doorfix (2014-03-20)August 28, 2014 · Medical devices · Medical devices · Type II
- Mani Paste Carriers, Paste Carriers (2014-07-31)August 28, 2014 · Medical devices · Medical devices · Type II
- TomoTherapy Treatment System H-series software versions 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1) (2014-07-17)August 28, 2014 · Medical devices · Medical devices · Type II
- Micro SSP Allele Specific HLA Class I DNA Typing Tray-C*02 (2014-03-25)August 28, 2014 · Medical devices · Medical devices · Type II
- Dimension Vista System-Hemoglobin A1C (HBA1C) A (2014-08-19)August 28, 2014 · Medical devices · Medical devices · Type III
- Da Vinci S, Si, and Si-e - battery box of patient side cart (2014-08-12)August 28, 2014 · Medical devices · Medical devices · Type III
- Treatment Table for Elekta Precise (2014-08-21)August 28, 2014 · Medical devices · Medical devices · Type II
- TomoTheraphy H Series software versions 1.2.0, 1.2.1, 1.2.2 (Hi-Art 4.2.0, 4.2.1, and 4.2.2) (2014-07-18)August 28, 2014 · Medical devices · Medical devices · Type II
- HIV combi PT (2014-08-27)August 27, 2014 · Medical devices · Medical devices · Type III
- Dimension Vista System - MMB Calibrator (2014-08-18)August 25, 2014 · Medical devices · Medical devices · Type III
- MicroScan's Microorganism Confirmation Panel (2014-08-14)August 25, 2014 · Medical devices · Medical devices · Type III
- Symbia T series Gamma Camera/CT Scanners (2014-08-06)August 25, 2014 · Medical devices · Medical devices · Type II
- Intellispace Portal (2014-07-30)August 25, 2014 · Medical devices · Medical devices · Type II
- Oxoid Tryptone T (2014-05-16)August 25, 2014 · Health products · Medical devices · Type III
- Hermes Evolution Knee System - Femoral Stems (2014-08-01)August 25, 2014 · Health products · Medical devices · Type II
- Monaco (2014-08-18)August 25, 2014 · Health products · Medical devices · Type II
- Biotrin Parvovirus B19 IgM (2014-08-19)August 25, 2014 · Health products · Medical devices · Type II
- McKesson Cardiology Hemo(2014-06-25)August 25, 2014 · Health products · Medical devices · Type II
- Focal Software CD (2014-08-18)August 25, 2014 · Medical devices · Medical devices · Type II
- Philips Intellispace Pacs (2014-07-30)August 25, 2014 · Medical devices · Medical devices · Type II
- E.Cam Signature Series and Symbia E Dual Head System (2014-07-29)August 25, 2014 · Medical devices · Medical devices · Type II
- Dimension Vista System - Chem Calibrators (2014-08-08)August 22, 2014 · Health products · Medical devices · Type III
- UniCel DxC 600i Synchron Access Clinical Analyzer (2014-08-04)August 22, 2014 · Medical devices · Medical devices · Type III
- Sarns Centrifugal Pump (2014-04-18)August 22, 2014 · Medical devices · Medical devices · Type III
- Intellispace ECG (2014-08-06)August 22, 2014 · Medical devices · Medical devices · Type II
- Pinnacle Therapy Planning System - Kit (2014-07-30)August 22, 2014 · Medical devices · Medical devices · Type II
- Advia 1200 Chemistry System - A1C_3 Calibrator and Advia Chemistry System - A1C_3 Calibrator (2014-08-07)August 22, 2014 · Medical devices · Medical devices · Type III
- Persona Knee-Tibial Articular Surface, Persona-CPS Tibial Articular Prov.(Top) and Persona-CPS Tibial Articular (Bottom) (2014-08-02)August 22, 2014 · Medical devices · Medical devices · Type II
- Claw and Claw II Plates (2014-08-01)August 22, 2014 · Medical devices · Medical devices · Type II
- Artis Zeego Multi-Axis and Artis Zee Multi-Purpose, Floor and Ceiling (2014-08-05)August 22, 2014 · Medical devices · Medical devices · Type III
- Columbia Agar with 5% Sheep Blood and Trypticase Soy Agar with 5% Sheep Blood (TSA II) / MacConkey II Agar (2014-07-10)August 22, 2014 · Medical devices · Medical devices · Type II
- Screen-Cyte 0.8% (2014-07-23)August 15, 2014 · Medical devices · Medical devices · Type III
- Rapid Response HUT Table (2014-07-11)August 15, 2014 · Medical devices · Medical devices · Type II
- BD PosiFlush T Pre-Filled Saline 10ml Syringe part of Cardinal Health Presource Kit (2014-07-31)August 15, 2014 · Medical devices · Medical devices · Type II
- 1.8mm Expandable LeMaitre Valvulotome (2014-07-28)August 15, 2014 · Medical devices · Medical devices · Type III
- Galt VTI Valved Tearaway Introducer Set and Galt VTI Standard Kit W/SP (2014-07-25)August 15, 2014 · Medical devices · Medical devices · Type II
- Cobas Integra - ALTL, ALTLP, ALTPM and ALT (2014-08-01)August 15, 2014 · Medical devices · Medical devices · Type III
- Spectra Optic Apheresis System (2014-07-29)August 15, 2014 · Medical devices · Medical devices · Type II
- Vitek 2 GN Card (2014-07-29)August 15, 2014 · Medical devices · Medical devices · Type III
- Her2 Fish System - 30 Test (2014-07-23)August 15, 2014 · Medical devices · Medical devices · Type II
- Persona Distal Valgus Alignment Guide (2014-07-31)August 8, 2014 · Medical devices · Medical devices · Type II
- 5mL Reaction Vessels used with the m2000sp Instrument (2014-07-09)August 8, 2014 · Medical devices · Medical devices · Type III
- Reuter Bivalve Fluoroplastic Intranasal Splint (2014-07-02)August 8, 2014 · Medical devices · Medical devices · Type III
- Blood Fluid Warmer Cassettes (2014-07-30)August 8, 2014 · Medical devices · Medical devices · Type II
- Accu-chek Mobile Monitor (2014-05-29)August 8, 2014 · Medical devices · Medical devices · Type II
- Morcellex Tissue and X-tract Morcellator, and Morcellex Sigma - Generator and Hand Piece (2014-07-31)August 8, 2014 · Medical devices · Medical devices · Type II
- Tri-Ex Extraction Balloon with Multiple Sizing (2014-07-14)August 8, 2014 · Medical devices · Medical devices · Type III
- Cobas IT 1000 Software (2014-07-24)August 8, 2014 · Medical devices · Medical devices · Type II
- Sarns Cannulae and Tenderflow Pediatric Venous Return Catheters (2014-07-25)August 8, 2014 · Medical devices · Medical devices · Type II
- Buretrol Solution Set with Clearlink and Interlink (2014-07-04)August 8, 2014 · Medical devices · Medical devices · Type I
- CoolSculpting System (also known as ZELTIQ Breeze System (2014-07-18)August 8, 2014 · Medical devices · Medical devices · Type III
- RE Turn 7400 and 7500 (2014-04-21)August 8, 2014 · Medical devices · Medical devices · Type III
- Sysmex Blood Coagulation Analyzer CS-2000i, CS-2100i and CS-5100 (2014-07-08)August 8, 2014 · Medical devices · Medical devices · Type III
- Reliance 1227 Cart & Utensil Washer Disinfector (2014-07-07)August 8, 2014 · Medical devices · Medical devices · Type III
- Cloversnare 4-Loop Vascular Retriever (2014-07-14)August 8, 2014 · Medical devices · Medical devices · Type II
- Steris 4085 General Surgical Table (2014-07-15)August 1, 2014 · Medical devices · Medical devices · Type II
- Variuos Instruments from Gelweave Vascular Prosthesis (2014-07-08)August 1, 2014 · Medical devices · Medical devices · Type II
- Dako Autostainer Link 48 with DakoLink (2014-07-01)August 1, 2014 · Medical devices · Medical devices · Type III
- Vitros ECI Immunodiagnostic Products CA 19-9 Reagent Pack - Calibrator (2014-07-17)August 1, 2014 · Medical devices · Medical devices · Type II
- Dako Autostainer Link 48 with DakoLink (2014-07-01)August 1, 2014 · Medical devices · Medical devices · Type III
- Essential NEO Audio/Visual Integration (2014-06-25)August 1, 2014 · Medical devices · Medical devices · Type II
- Dimension Chemistry System, Dimension Clinical Chemistry System, Dimension EXL System and Dimension XPAND System (2014-07-11)August 1, 2014 · Medical devices · Medical devices · Type II
- Clinical Chemistry ICT Serum Calibrator (2014-07-25)August 1, 2014 · Medical devices · Medical devices · Type II
- BD Max MRSA Assay (2014-07-18)August 1, 2014 · Medical devices · Medical devices · Type III
- HeartSine Samaritan PAD SAM 350P (2014-06-12)August 1, 2014 · Medical devices · Medical devices · Type III
- Discovery XR656 Digital Radiographic System (2014-07-24)August 1, 2014 · Medical devices · Medical devices · Type II
- Vitros System (2014-07-07)July 25, 2014 · Medical devices · Medical devices · Type II
- Grab 'N' Go,Ezox Easycarry and All-in-one oxygen regulators (2014-07-02)July 25, 2014 · Medical devices · Medical devices · Type II
- Portex Endotracheal Tube Holders, Sizes 2.5mm and 3.0mm (2014-07-11)July 25, 2014 · Medical devices · Medical devices · Type II
- Vitros Chemistry Products NH3 DT Slides (2014-07-16)July 25, 2014 · Medical devices · Medical devices · Type II
- DX-D 600 Full Automatic System (2014-07-02)July 25, 2014 · Medical devices · Medical devices · Type II
- Various Femoral Arterial and Venous Cannula (2013-12-05)July 25, 2014 · Medical devices · Medical devices · Type III
- Automatically Change Over Valve for Gas Bottles (CO2) UGV 1 (2014-05-09)July 25, 2014 · Medical devices · Medical devices · Type III
- Gyrus ACMI Falope-Ring Dilator (2014-07-09)July 25, 2014 · Medical devices · Medical devices · Type II
- Various Inline Valve Catheter and its Accessories (2014-07-17)July 25, 2014 · Medical devices · Medical devices · Type II
- MI1000 Pin Drill (2014-03-21)July 25, 2014 · Medical devices · Medical devices · Type III
- Dimension EXL System (2014-07-15)July 25, 2014 · Medical devices · Medical devices · Type III
- Blood Grouping Reagent MTS A/B/D Monoclonal and Reverse Grouping Card (2014-07-07)July 25, 2014 · Medical devices · Medical devices · Type II
- Versant HCV Genotype 2.0 Kit (LIPA) (2014-07-09)July 22, 2014 · Medical devices · Medical devices · Type III
- Kodak Directview DR 7500 system (2014-07-11)July 22, 2014 · Medical devices · Medical devices · Type II
- Integra LED Battery Charger, Single Bay (2014-06-11)July 22, 2014 · Medical devices · Medical devices · Type II
- Prisma, Oxiris and various Prismaflex Sets (2014-06-27)July 22, 2014 · Medical devices · Medical devices · Type II
- Sonopet Ultrasonic Aspirator Console (2014-07-03)July 22, 2014 · Medical devices · Medical devices · Type II
- Intouch Bed Caster Stem (2014-07-02)July 22, 2014 · Medical devices · Medical devices · Type II
- Mars Treatment Kits (2014-06-27)July 22, 2014 · Medical devices · Medical devices · Type II
- Various Dimension - Automated HDL Chloesterol (AHDL) Assay (2014-07-10)July 22, 2014 · Medical devices · Medical devices · Type III
- Filtek Supreme Ultra Flowable Restorative (2014-06-26)July 22, 2014 · Medical devices · Medical devices · Type III
- S5 Mast Mounted Roller Pumps (MRP) 85 (2014-07-09)July 22, 2014 · Medical devices · Medical devices · Type II
- Trigen Titanium Nail System - Intertan Short Nail (2014-07-07)July 22, 2014 · Medical devices · Medical devices · Type II
- Tenor Mobile Patient Lifter (Non-Scale Version) (2014-04-10)July 22, 2014 · Medical devices · Medical devices · Type II
- Angiojet Ultra Thrombectomy System (2014-06-12)July 15, 2014 · Medical devices · Medical devices · Type II
- Oxoid Legionella pneumophila 2-14 Reagent (2014-07-08)July 15, 2014 · Medical devices · Medical devices · Type III
- Horizon Medical Imaging Management System (2014-05-21)July 15, 2014 · Medical devices · Medical devices · Type II
- Advia Centaur XP System Reagents (2014-06-04)July 15, 2014 · Medical devices · Medical devices · Type III
- On-Board Imager (2014-03-20)July 15, 2014 · Medical devices · Medical devices · Type II
- OMNI-Lab - Laboratory Information System (2014-06-16)July 15, 2014 · Medical devices · Medical devices · Type II
- Lasertubus Endotracheal Tube (2014-06-12)July 15, 2014 · Medical devices · Medical devices · Type II
- SmartPeg (2014-05-27)July 15, 2014 · Medical devices · Medical devices · Type III
- LIFEPAK 1000 Defibrillator (2014-06-05)July 15, 2014 · Medical devices · Medical devices · Type II
- BD Vacutainer CPT Mononuclear Cell Preparation Tube (2014-06-27)July 15, 2014 · Medical devices · Medical devices · Type III
- Empira NC RX PTCA and Empira RX PTCA Dilatation Catheter Products (2014-06-24)July 15, 2014 · Medical devices · Medical devices · Type II
- Essential NEO Audio/Visual Integration Unit (2014-06-25)July 15, 2014 · Medical devices · Medical devices · Type II
- McKesson Radiology - PACS (2014-04-17)July 15, 2014 · Medical devices · Medical devices · Type II
- Various Clinac High Energy Linear Accelerator (2014-06-17)July 15, 2014 · Medical devices · Medical devices · Type II
- RapidQC Complete Level 2 (2014-07-03)July 15, 2014 · Medical devices · Medical devices · Type III
- Portable Programming System, Nucleus 24 Auditory Brainstem Implant System and Nucleus 24 Channel Cochlear Implant System (2014-06-19)July 15, 2014 · Medical devices · Medical devices · Type III
- Spinning Spiros (2014-06-17)July 15, 2014 · Medical devices · Medical devices · Type III
- Olerup SSP - SSP Combi Trays (2014-05-29)July 15, 2014 · Medical devices · Medical devices · Type II
- Periarticular and Cancellous Screw (2014-06-23)July 15, 2014 · Medical devices · Medical devices · Type II
- BBLT Crystal Enteric/Nonfermenter ID Kit (2014-05-22)July 15, 2014 · Medical devices · Medical devices · Type III
- Insight and Ultra-Speed (2014-07-02)July 10, 2014 · Medical devices · Medical devices · Type III
- Nexdrive Micropositioning Drive Models ML-1000 and ML-2000 (2014-06-19)July 10, 2014 · Medical devices · Medical devices · Type II
- Plum A+ Volumetric Infusion Pumps and Plum A+3 Infusion Pumps (2014-06-26)July 10, 2014 · Medical devices · Medical devices · Type II
- 840 Ventilator System - Main Unit (2014-06-10)July 10, 2014 · Medical devices · Medical devices · Type II
- ReClaim Distal Tapered Stem and ReClaim Taper Sleeve Protector (2014-06-27)July 10, 2014 · Medical devices · Medical devices · Type II
- Ultrasound Gastroscopes (2014-06-28)July 10, 2014 · Medical devices · Medical devices · Type II
- Advanced Perfusion System 1, Base Unit (2014-06-27)July 10, 2014 · Medical devices · Medical devices · Type III
- Moore Hip Long Fenestrated Stem (2014-07-03)July 10, 2014 · Medical devices · Medical devices · Type II
- Various Biograph mCT-S Devices (2014-06-23)July 10, 2014 · Medical devices · Medical devices · Type III
- 840 Ventilator System - Main Unit (2014-06-12)July 10, 2014 · Medical devices · Medical devices · Type II
- Oxoid Beta Lactamase Identification Sticks (2014-05-26)July 7, 2014 · Medical devices · Medical devices · Type III
- ITC Hemochron JR APTT Test Cuvette (2014-06-24)July 7, 2014 · Medical devices · Medical devices · Type II
- IVF Pasteur Pipet (2014-06-23)July 7, 2014 · Medical devices · Medical devices · Type III
- Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites and Interlink Injection Sites (2014-06-10)July 7, 2014 · Medical devices · Medical devices · Type II
- Gemini TF16 PET/CT System - Main Unit (2014-06-18)July 7, 2014 · Medical devices · Medical devices · Type II
- Various Linear Accelerators Oncor Systems (2014-06-03)July 7, 2014 · Medical devices · Medical devices · Type II
- IMUBIND Adamts13 ELISA and Auto Ab ELISA (2014-06-26)July 7, 2014 · Medical devices · Medical devices · Type III
- Advia Centaur CP System- B-Type Natriuretic Peptide (BNP) Assay (2014-03-24)July 7, 2014 · Medical devices · Medical devices · Type III
- Biotestcell -I 8 and I 11 (2014-06-17)July 7, 2014 · Medical devices · Medical devices · Type I
- Disposable Strykeflow Tip (2014-06-23)July 7, 2014 · Medical devices · Medical devices · Type II
- Proteus XR/A General Purpose Radiographic System and Revolution XR/D Digital Radiographic System (2014-06-12)July 3, 2014 · Medical devices · Medical devices · Type II
- Artiste MV System - Digital Linear Accelerator (2014-06-12)July 3, 2014 · Medical devices · Medical devices · Type III
- Cobas IT 1000 Software (2014-05-02)July 3, 2014 · Medical devices · Medical devices · Type III
- 2008T Hemodialysis Machine (2014-05-28)July 3, 2014 · Medical devices · Medical devices · Type III
- Brightview XCT Imaging System - Tilt System (2014-06-13)July 3, 2014 · Medical devices · Medical devices · Type II
- Affinity Four Birthing Beds P3700B (2014-06-20)July 3, 2014 · Medical devices · Medical devices · Type II
- Intelepacs - Main Unit (2014-06-13)July 3, 2014 · Medical devices · Medical devices · Type II
- Mckesson Horizon Medical Imaging and Mckesson Radiology 12.0 (2014-05-05)July 3, 2014 · Medical devices · Medical devices · Type II
- Da Vinci S Surgical System, Da Vinci SI System and Da Vinci Surgical System (2014-06-03)July 3, 2014 · Medical devices · Medical devices · Type II
- Minicap Disconnect (2014-06-17)July 3, 2014 · Medical devices · Medical devices · Type II
- HydroFinity Hydrophilic Guidwire(2014-06-03)July 3, 2014 · Medical devices · Medical devices · Type II
- Behring Nephelometer System - N Latex IGE (2014-06-16)July 3, 2014 · Medical devices · Medical devices · Type III
- Stellant with Certegra Workstation - Stellant CT (2014-06-12)July 3, 2014 · Medical devices · Medical devices · Type II
- Shaver Handpiece Sterilization Tray (2014-05-30)July 3, 2014 · Medical devices · Medical devices · Type III
- Mobilediagnost WDR (2014-06-17)July 3, 2014 · Medical devices · Medical devices · Type II
- V-mark Breast Biopsy Site Marker and Biopince Biopsy Needle (2014-05-29)July 3, 2014 · Medical devices · Medical devices · Type III
- ACL Top Family Devices (2014-06-03)July 3, 2014 · Medical devices · Medical devices · Type II
- Da Vinci S Surgical System- Endoscopic Instrumentation, Large HEM-O-LOK clip applier and Large HEM-O-LOK clip applier (2014-06-13)July 3, 2014 · Medical devices · Medical devices · Type II
- WaterLase iPlus Dental Laser System (2014-06-03)July 3, 2014 · Medical devices · Medical devices · Type II
- Advia Centaur XP and CP System and Advia Centaur System (2014-06-04)July 3, 2014 · Medical devices · Medical devices · Type II
- Coat-a-Count Direct Androsrenedione Kit (2014-06-12)June 24, 2014 · Medical devices · Medical devices · Type III
- Banitore Elbow, Wrist, Knee and Ankle Support (2014-06-04)June 24, 2014 · Medical devices · Medical devices · Type III
- Artis Zeego and Artis Zee Multi-purpose, Floor, Celing and Biplane (2014-06-12)June 24, 2014 · Medical devices · Medical devices · Type II
- Salmonella Agglutinating Serum HZ15 (2014-06-09)June 24, 2014 · Medical devices · Medical devices · Type III
- Wellcolex Colour Salmonella Kit (2014-05-22)June 24, 2014 · Medical devices · Medical devices · Type II
- Somatom Emotion 16-slice Configuration (2014-06-17)June 24, 2014 · Medical devices · Medical devices · Type II
- Minicap Extended life PD Transfer Set (2014-05-28)June 24, 2014 · Medical devices · Medical devices · Type I
- Axiom Artis DTA,Artis Zeego and Artis Zee- Multi-purpose, Floor, Celing and Biplane (2014-06-11)June 24, 2014 · Medical devices · Medical devices · Type III
- Part # 5027FP sealed Rrechargeable Battery (2014-05-01)June 24, 2014 · Medical devices · Medical devices · Type III
- Qube Compact Monitor (2014-06-06)June 24, 2014 · Medical devices · Medical devices · Type II
- Cobas IT Middleware (2014-05-29)June 24, 2014 · Medical devices · Medical devices · Type II
- Langston V2 Dual Lumen Catheter (2014-05-23)June 19, 2014 · Medical devices · Medical devices · Type II
- Central venous Catheterization Kits/Sets,Arrowg+ard Venous Catheter Kits/Sets and Arrowg+agb Blue Plus Pressure Injectable Central Venous Catheterization Set ( 2014-05-29)June 19, 2014 · Medical devices · Medical devices · Type III
- Rapidpoint 500 system - Lactate Measurement Cartridges (2014-05-30)June 19, 2014 · Medical devices · Medical devices · Type III
- Encore Hydrasoft Latex PWD Free Surgical Glove (2014-05-27)June 19, 2014 · Medical devices · Medical devices · Type II
- Stereos Workstation System Logiciel EOS 3D Recons (2013-11-29)June 19, 2014 · Medical devices · Medical devices · Type II
- Drill Bit (2014-06-09)June 19, 2014 · Medical devices · Medical devices · Type II
- Versys Beaded Fullcoat Stem - Standard,Offset and Stem-Offset (LM) (2014-06-03)June 19, 2014 · Medical devices · Medical devices · Type II
- Walkaway Plus System - 40 - Instrument (2014-06-05)June 18, 2014 · Medical devices · Medical devices · Type II
- Various Teosyal Products (2014-06-09)June 18, 2014 · Medical devices · Medical devices · Type II
- M/L Taper Reduced Neck Stems, M/L Taper Reduced Neck Extended Offset,M/L Taper with Kinectiv Stems,M/L Taper Standard Stems and M/L Taper Extended Offset Stems (2014-06-06)June 18, 2014 · Medical devices · Medical devices · Type II
- Kodak Directview DR 9000 System (2014-06-02)June 18, 2014 · Medical devices · Medical devices · Type II
- Mosaiq (2014-05-29)June 18, 2014 · Medical devices · Medical devices · Type II
- Zeus IE Anesthesia Workstation (2014-05-30)June 18, 2014 · Medical devices · Medical devices · Type II
- CARINAiso and CARINAsim Laser Marking System (2013-11-08)June 18, 2014 · Medical devices · Medical devices · Type II
- Gel-E Donut and Squishon 2 (2014-05-28)June 18, 2014 · Medical devices · Medical devices · Type II
- TPS System - Precision Neuro Drill,Elite Burs,Neuro Drill andZyphr Elite Round Fluted Bur (2014-05-23)June 18, 2014 · Medical devices · Medical devices · Type II
- I-Guide System 2.X incl. Workstation (2014-05-29)June 18, 2014 · Medical devices · Medical devices · Type II
- Triage B-type Natriuretic Peptide (BNP) test for the Beckman Coulter Immunoassay Systems (2014-06-03)June 18, 2014 · Medical devices · Medical devices · Type II
- Eye-Pak Tray Support Cover (2014-06-06)June 18, 2014 · Medical devices · Medical devices · Type II
- SmartMonitor 2 Professional Series (2014-04-29)June 12, 2014 · Medical devices · Medical devices · Type II
- Langston V2 Dual Lumen Catheter (2014-05-23)June 12, 2014 · Medical devices · Medical devices · Type II
- AGFA Digital Radiography X-ray System DX-D 100 (2014-06-06)June 12, 2014 · Medical devices · Medical devices · Type I
- Male Luer Lock Plug (2014-05-27)June 12, 2014 · Medical devices · Medical devices · Type III
- ITS4850A Intellivue Telemetry System - Moinitor (2014-05-20)June 12, 2014 · Medical devices · Medical devices · Type II
- Para Post System Plastic Burnout Post (2014-05-16)June 12, 2014 · Medical devices · Medical devices · Type II
- Array Laserlink (2014-04-21)June 12, 2014 · Medical devices · Medical devices · Type II
- Hemospray Kit/Hemospray Endoscopic Hemostat (2014-05-21)June 12, 2014 · Medical devices · Medical devices · Type II
- Kamra Corneal Inlay ACI 7000 (2013-11-08)June 12, 2014 · Medical devices · Medical devices · Type III
- Spheres, Navigus Trajectory Guide and Fixator Pins - Stainless Steel (2014-05-06)June 12, 2014 · Medical devices · Medical devices · Type III
- Solar 8000I System - Patient Monitor (2014-01-27)June 12, 2014 · Medical devices · Medical devices · Type III
- Advantx Legacy and Precision 500D System (2013-09-04)June 12, 2014 · Medical devices · Medical devices · Type II
- Mentor Gel Sizers (2014-05-27)June 12, 2014 · Medical devices · Medical devices · Type II
- Acuson S2000 and 3000 Ultrasound System (2014-05-21)June 12, 2014 · Medical devices · Medical devices · Type II
- Vesrsatouch, Safeway, No Name and Viking Disposable Gloves (2014-02-05)June 12, 2014 · Medical devices · Medical devices · Type II
- Architect I System - EBV VCA IgM controls (2014-05-14)June 5, 2014 · Medical devices · Medical devices · Type III
- RP 360-Degree Suture Passer(2014-05-13)June 5, 2014 · Medical devices · Medical devices · Type III
- MacroLyte Premie Dispersive Electrode(2014-05-12)June 5, 2014 · Medical devices · Medical devices · Type II
- Single Width Airway Module(2014-05-21)June 5, 2014 · Medical devices · Medical devices · Type II
- Axiom Artis and Artis Zee Devices (2014-05-14)June 5, 2014 · Medical devices · Medical devices · Type III
- Path Thread Cup Adaptor (2014-04-29)June 5, 2014 · Medical devices · Medical devices · Type II
- Sterile Field Towel / Drape (2014-04-30)June 5, 2014 · Medical devices · Medical devices · Type III
- Tecnis CL Foldable Silicone IOL (2014-05-15)June 5, 2014 · Medical devices · Medical devices · Type II
- Acuson S2000 and Acuson S3000 Ultrasound System (2014-05-20)June 5, 2014 · Medical devices · Medical devices · Type III
- Alaris PC Unit Model 8015(2013-06-17)June 5, 2014 · Medical devices · Medical devices · Type II
- Microscan NEG BP Combo Panel(2014-05-20)June 5, 2014 · Medical devices · Medical devices · Type III
- Alaris Pump Module Model 8100(2014-04-23)June 5, 2014 · Medical devices · Medical devices · Type I
- Corometrics 174 Series Monitor(2014-05-12)June 5, 2014 · Medical devices · Medical devices · Type III
- Vitros Chemisty Products HSCRP Reagent (2014-05-12)June 5, 2014 · Medical devices · Medical devices · Type III
- Trigen Titanium Nail System - Intertan Short Nails (2014-04-07)June 5, 2014 · Medical devices · Medical devices · Type II
- Flamingo Inflation System - Robinet and Flamingo Inflation System (2013-03-21)June 5, 2014 · Medical devices · Medical devices · Type II
- Gluma Desensitizer Powergel (2014-04-23)June 5, 2014 · Medical devices · Medical devices · Type II
- Support Boards Securis Beds For Euro (2014-05-02)June 5, 2014 · Medical devices · Medical devices · Type II
- Rapidfill Syringe Strip (2014-04-04)June 5, 2014 · Medical devices · Medical devices · Type II
- Acuson SC2000 Ultrasound System - Mainframe (2014-01-10)June 5, 2014 · Medical devices · Medical devices · Type III
- DSR 5000R Dip Drugscan Reader et QSR 6000R Quikscreen Drug Cup Reader (2013-04-19)June 5, 2014 · Medical devices · Medical devices · Type II
- Airgo Fusion Rollator(2014-04-28)June 5, 2014 · Medical devices · Medical devices · Type II
- Toxcup Amp/Coc/Opi/Pcp/Thc Drug Screen Cup with Adulteration Pads (2014-03-26)June 5, 2014 · Medical devices · Medical devices · Type II
- X Series/PropaqMD/PropaqM monitor/defibrillator running software version 02.10.02.00 or higher (2014-03-10)June 5, 2014 · Medical devices · Medical devices · Type II
- Incision and Drainage Kits(2014-02-19)June 5, 2014 · Medical devices · Medical devices · Type II
- ADVIA Chemistry and ADVIA 1200 Chemistry System (2014-04-29)June 5, 2014 · Medical devices · Medical devices · Type III
- Heparin I.V. Flush Syringe(2014-02-19)June 5, 2014 · Medical devices · Medical devices · Type II
- TUR Y-set for Transurethral Resection and Cystoscopy Irrigation Set(2014-03-31)June 5, 2014 · Medical devices · Medical devices · Type II
- Mammomat Inspiration System - Acquisition Workstation (2014-05-02)June 5, 2014 · Medical devices · Medical devices · Type III
- Hermes Posterior Stabilized Knee - Tibial Base PL (2014-05-06)June 5, 2014 · Medical devices · Medical devices · Type II
- Weck Vista Products (2014-03-24)June 5, 2014 · Medical devices · Medical devices · Type II
- Navigus Trajectory Guide,Fixator Pins- Stainless Steel and Axiem-Instrument Kit(2014-05-06)June 5, 2014 · Medical devices · Medical devices · Type III
- GammaMed Brachytherapy Applicator Set (2014-03-20)June 5, 2014 · Medical devices · Medical devices · Type II
- Ultra Ninhydrin Kit and Lithium Buffer (2014-05-09)June 5, 2014 · Medical devices · Medical devices · Type III
- Capio Polyester and Polypropylene Nonabsorbable Surgical Sutures (2014-03-11)June 5, 2014 · Medical devices · Medical devices · Type II
- Access System,Unicel DXI 600 Access Immunoassay System and Unicel DXI 800 Access Immunoassay System-Total BhCG assay (2014-04-10)June 5, 2014 · Medical devices · Medical devices · Type III
- Milling Bit with Shaft-Sterilie (2014-05-05)June 5, 2014 · Medical devices · Medical devices · Type II
- Cobas 6000 - E601, Modular Analytics E Combinations Analyzer (E170) and Cobas 8000 E602 Immunoassay Analyzer (2014-05-07)June 5, 2014 · Medical devices · Medical devices · Type II
- Leica PARAPLAST PLUS Tissue Embedding Medium (2013-07-19)June 5, 2014 · Medical devices · Medical devices · Type III
- Unicel DXC600i Synchron Access Integrated Clinical Systems, and Unicel DXI 800 and Unicel DXI 600 Access Immunoassay Systems (2014-05-10)June 5, 2014 · Medical devices · Medical devices · Type II
- MOSAIQ (2014-05-14)June 5, 2014 · Medical devices · Medical devices · Type II
- Synchron Systems Ammonia (AMM) Reagent(2014-05-01)June 5, 2014 · Medical devices · Medical devices · Type III
- Xiris(2014-05-08)June 5, 2014 · Medical devices · Medical devices · Type II
- Intera 1.5T MRI System-Main Unit(2014-05-08)June 5, 2014 · Medical devices · Medical devices · Type II
- NovaPACS (2013-05-14)June 5, 2014 · Medical devices · Medical devices · Type III
- Compass 3.0 (2013-08-19)June 5, 2014 · Medical devices · Medical devices · Type II
- CARESCAPE Monitor B650(2014-05-23)June 5, 2014 · Medical devices · Medical devices · Type II
- Various IND Diagnostic Inc. Test Kits (2014-04-28)June 5, 2014 · Medical devices · Medical devices · Type II
- Saber Bulb KIT (2014-03-20)June 5, 2014 · Medical devices · Medical devices · Type II
- PentaRay NAV and PentaRay NAV ECO Catheter (2014-05-07)June 5, 2014 · Medical devices · Medical devices · Type II
- Ingenia 1.5T (2014-05-14)June 4, 2014 · Medical devices · Medical devices · Type II
- Accusorb MRI Products (2014-06-01)June 1, 2014 · Medical devices · Medical devices · Type II
- Architect System - Hemoglobin A1C Calibrators(2014-05-02)May 26, 2014 · Medical devices · Medical devices · Type II
- D2rs-Digital Dynamic Remote SystemMay 25, 2014 · Medical devices · Type II
- Information Regarding the Transvaginal Implantation of Surgical Mesh Devices for the Treatment of Pelvic Organ Prolapse and Stress Urinary IncontinenceMay 13, 2014 · Medical devices
- Surgical Mesh - Complications Associated with Transvaginal Implantation for the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse - Notice to HospitalsMay 13, 2014 · Medical devices · Product safety
- Percutaneous Sheath Introducer Kits with Silk Sutures (2014-05-01)May 8, 2014 · Medical devices · Medical devices · Type II
- Unicel DXC 600, 600I, and 800 Synchron Access Clinical Analyzers (2014-04-23)May 8, 2014 · Medical devices · Medical devices · Type III
- Advia Centaur System TSH3 Ultra and Procalcitonin Assays and Vitamin D Total Reagent (2014-04-14)May 8, 2014 · Medical devices · Medical devices · Type III
- Giraffe and Panda Warmers (2014-04-02)May 8, 2014 · Medical devices · Medical devices · Type II
- Sapien XT Transcatheter with Ascendra Delivery System and Edwards Sapien XT Transcatheter with Novaflex Delivery System (2013-04-17)May 8, 2014 · Medical devices · Medical devices · Type III
- Ventralight ST Mesh with Echo - Ellipse and Echo (2014-04-29)May 8, 2014 · Medical devices · Medical devices · Type III
- Hudson RCI Humidifier Adaptor (2014-04-25)May 8, 2014 · Medical devices · Medical devices · Type III
- Bluephase Style Pin-Point Light Probe (2014-04-25)May 8, 2014 · Medical devices · Medical devices · Type II
- Advanced Perfusion System 1 - Base Unit (2013-04-23)May 8, 2014 · Medical devices · Medical devices · Type II
- Apex Daily Wear Contact Lenses (2014-04-23)May 8, 2014 · Medical devices · Medical devices · Type III
- Maquet Critical Care Servos U and N (2014-04-17)May 8, 2014 · Medical devices · Medical devices · Type II
- Reagent for Bond Max System - Thyroglobulin (2014-04-04)May 8, 2014 · Medical devices · Medical devices · Type III
- Laparoscopic Electric Morcellators - Risk of Spread of Unsuspected Uterine Sarcoma - Notice to HospitalsMay 7, 2014 · Medical devices · Product safety
- Orthoquad DS1400 (2013-07-31)May 6, 2014 · Medical devices · Medical devices · Type II
- Compact Airway Module (2014-04-21)May 6, 2014 · Medical devices · Medical devices · Type II
- Hexapod Evo-RT-Couchtop (2014-04-17)May 6, 2014 · Medical devices · Medical devices · Type II
- Neo-Temp Resin Cement and Opotow Temporary Cement (2014-04-14)May 6, 2014 · Medical devices · Medical devices · Type II
- Hamilton - G5 Ventilator (2014-04-17)May 6, 2014 · Medical devices · Medical devices · Type II
- CT Express Hand Switch (2014-04-23)May 6, 2014 · Medical devices · Medical devices · Type II
- PowerLED 700 and H. LED 700 (2014-03-14)May 6, 2014 · Medical devices · Medical devices · Type II
- Soft Tissue Gauge - 6 mm (2014-04-17)May 6, 2014 · Medical devices · Medical devices · Type II
- Femoral Arterial Cannula - Fem-Flex II and Duraflo II Fem-Flex II (2014-04-09)May 5, 2014 · Medical devices · Medical devices · Type II
- Profile Series 29 Hand File (2014-04-09)May 5, 2014 · Medical devices · Medical devices · Type II
- Microvascular Free Flap and Sterile Head and Neck Major Pack (2014-04-07)May 5, 2014 · Medical devices · Medical devices · Type II
- Sysmex Blood Coagulation Analyzer CS-2000I et 5100 (2014-03-14)May 5, 2014 · Medical devices · Medical devices · Type III
- Axiom Luminos DRF System-Main Unit (2014-04-22)May 5, 2014 · Medical devices · Medical devices · Type II
- Vitros Systems (2014-04-11)May 5, 2014 · Medical devices · Medical devices · Type III
- Bubble CPAP System, Components and Nasal Prong (2014-04-11)May 5, 2014 · Medical devices · Medical devices · Type II
- Sprotte Pencil Point Spinal Needle 24 Gauge with Introducer (2014-04-03)May 5, 2014 · Medical devices · Medical devices · Type II
- Xenosure Biological Vascular Patch (2014-04-18)May 5, 2014 · Medical devices · Medical devices · Type III
- Thermocool SF Nav Catheters - Uni and Bi-Directional (2014-04-04)May 5, 2014 · Medical devices · Medical devices · Type II
- Syngo Imaging - System Luk (2014-04-17)May 5, 2014 · Medical devices · Medical devices · Type II
- Cardiovascular Procedure Kits (2013-07-26)May 5, 2014 · Medical devices · Medical devices · Type III
- Medrad Stellant with Certegra Workstation(2014-05-01)May 1, 2014 · Medical devices · Medical devices · Type II
- CMF Distraction System - AB and BC Craniofacial Distractor Bodies (2014-04-16)April 30, 2014 · Medical devices · Medical devices · Type I
- Actiwatch Spectrum Plus (2014-02-28)April 30, 2014 · Medical devices · Medical devices · Type II
- Synthes External Fixation Systems related to Magnetic Resonance (MR) conditions (2014-04-11)April 30, 2014 · Medical devices · Medical devices · Type II
- Coiled Tube Infusor (2014-04-10)April 30, 2014 · Medical devices · Medical devices · Type II
- Medrad CT 200 mL Syringes (2014-04-10)April 30, 2014 · Medical devices · Medical devices · Type II
- Intra-Aortic Balloon Pumps - Systems 98, 98XT, CS100, CS100I, and CS300 (2014-03-24)April 30, 2014 · Medical devices · Medical devices · Type II
- Architect System - Lipase Assay (2014-04-12)April 30, 2014 · Medical devices · Medical devices · Type II
- Titanium Orthos Brackets (2014-03-25)April 30, 2014 · Medical devices · Medical devices · Type II
- Liquichek Autoimmune Negative Control (2014-04-01)April 30, 2014 · Medical devices · Medical devices · Type III
- Heartstart XL+ (2014-03-31)April 30, 2014 · Medical devices · Medical devices · Type II
- Rita Main Cable (2014-01-08)April 30, 2014 · Medical devices · Medical devices · Type II
- Mobilediagnost WDR (2014-01-10)April 30, 2014 · Medical devices · Medical devices · Type II
- Dimension Vista 500 and Dimension Vista 1500 System Analyzers (2014-04-09)April 30, 2014 · Medical devices · Medical devices · Type II
- Siemens Server and Workstation Software (2014-04-11)April 30, 2014 · Medical devices · Medical devices · Type II
- Infinix CF-1/BP-System (2014-04-04)April 30, 2014 · Medical devices · Medical devices · Type II
- Global APG+ 2.5 mm Breakaway Guide Pin (2014-04-02)April 30, 2014 · Medical devices · Medical devices · Type II
- MI1000 Pin Drill (2014-03-24)April 30, 2014 · Medical devices · Medical devices · Type III
- Engen Automated Sample Handling System (2014-04-11)April 30, 2014 · Medical devices · Medical devices · Type II
- Intellivue MP and X2 Patient Monitor Systems (2014-04-04)April 30, 2014 · Medical devices · Medical devices · Type II
- Triage BNP Assay for Beckman Coulter Inc. Immunoassay Systems (2014-03-26)April 30, 2014 · Medical devices · Medical devices · Type II
- Angiotensin Converting Enzyme (ACE) Kit (2014-01-10)April 30, 2014 · Medical devices · Medical devices · Type III
- GE Datex-Ohmeda Anestheisa Systems (2013-08-28)April 30, 2014 · Medical devices · Medical devices · Type III
- Etchmaster CO2 Cartridge (2010-12-16)April 30, 2014 · Medical devices · Type II
- Indicator One-Step Home Pregnancy Test (Midstream Format) and LH Ovulation Test (Strip Format) (2013-08-09)April 30, 2014 · Medical devices · Medical devices · Type II
- Da Vinci SI 5 x 300 mm Curved Canula - Arm 1 and Arm 2 (2014-02-28)April 30, 2014 · Medical devices · Medical devices · Type II
- Unicel DXC 600, DXC 800, and DXC 600I Synchron Access Clinical Analyzer (2014-03-20)April 30, 2014 · Medical devices · Medical devices · Type II
- Aliquot Plates (2014-04-28April 28, 2014 · Medical devices · Medical devices · Type III
- Morcellex tissue morcellator and Morecellex Sigma generator (2014-04-28)April 28, 2014 · Medical devices · Medical devices · Type II
- 12-Instrument Sterilization Tray (2014-04-25)April 25, 2014 · Medical devices · Medical devices · Type III
- Variant II Beta-Thalassemia Short Program (2014-04-25)April 25, 2014 · Medical devices · Medical devices · Type III
- Becton Dickinson Nexiva Closed IV Catheter System and Nexiva Diffusics Closed IV Catheter System (2014-02-14)April 22, 2014 · Medical devices · Medical devices · Type III
- Immage Immunochemistry Systems Apolipoprotein A-1 (APA) and Apolipoprotein Calibrator (Apo Cal) (2014-03-26)April 22, 2014 · Medical devices · Medical devices · Type III
- D-10 Haemoglobin Testing System - Analyzer (2014-03-14)April 22, 2014 · Medical devices · Medical devices · Type II
- Safeway Dental Floss (2014-01-08)April 22, 2014 · Medical devices · Medical devices · Type III
- OEC 9900 Workstation Monitor Spring Arm Screws (2014-04-03)April 22, 2014 · Medical devices · Medical devices · Type II
- Cedia TDM Assay - Tobramycin II (2013-10-16)April 22, 2014 · Medical devices · Medical devices · Type III
- Millenium, Hawkeye, Hawkeye 4, Infinia, and Varicam Gamma Cameras and Helix Nuclear Medical Systems (2014-02-12)April 17, 2014 · Medical devices · Medical devices · Type II
- Clinac and Trilogy - Linear Accelerator, High Energy Accelerators and Radiotherapy Delivery Systems (2013-10-24)April 15, 2014 · Medical devices · Medical devices · Type II
- Dimension Vista System - Cyclosporine Extended Range (CSAE) and Cyclosporine (CSA) Assays (2014-03-14)April 15, 2014 · Medical devices · Medical devices · Type II
- Brilliance CT Systems and Ingenuity CT System (2014-04-01)April 15, 2014 · Medical devices · Medical devices · Type II
- Alligator Retrieval Device (2014-04-03)April 15, 2014 · Medical devices · Medical devices · Type I
- Trabecular Metal Acetabular Shell (2014-04-02)April 15, 2014 · Medical devices · Medical devices · Type II
- Vitros Chemistry DIluent and Vitros Chemistry FS Specialty Diluent Pack 3 (2014-03-27)April 15, 2014 · Medical devices · Medical devices · Type II
- Disposable Biopsy Forceps (2014-03-25)April 15, 2014 · Medical devices · Medical devices · Type III
- Ingenuity CT System (2014-03-26)April 15, 2014 · Medical devices · Medical devices · Type II
- Cobas 8000 - C502 Chemistry Analyzer (2014-03-27)April 15, 2014 · Medical devices · Medical devices · Type II
- Advia Centaur and Advia Centaur XP Systems - C-Peptide (CPS) Assay (2014-03-28)April 15, 2014 · Medical devices · Medical devices · Type III
- Advia Centaur, Centaur CP, and Centaur XP Systems - HIV Ag/Ab Combo (Chiv) Assay (Donor Screen Transplant) (2014-03-28)April 15, 2014 · Medical devices · Medical devices · Type III
- Oncor Expression Digital Linear Accelerator, Artiste MV-Linear Accelerator, and Oncor Impression IMRT Plus (2014-03-27)April 15, 2014 · Medical devices · Medical devices · Type II
- Non Absorbable Surgical Suture Stainless Steel (2014-03-24)April 15, 2014 · Medical devices · Medical devices · Type II
- Unicel DXH 600 and Unicel DXH 800 Coulter Cellular Analysis Systems (2014-03-13)April 15, 2014 · Medical devices · Medical devices · Type II
- Sarns Dual-Stage Malleable Venous Return Catheter (2014-03-07)April 15, 2014 · Medical devices · Medical devices · Type III
- Prestix and Prestige Remote Controlled Tables (2014-02-18)April 15, 2014 · Medical devices · Medical devices · Type III
- Immulite and Immulite 2000 Anti-Tg AB Systems and Immulite 1000 System - Thyroid Autoantibody Assay (2014-03-24)April 14, 2014 · Medical devices · Medical devices · Type III
- Artis Zeego Multi-Axis (2014-03-21)April 14, 2014 · Medical devices · Medical devices · Type III
- Paradigm Insulin Pumps and Paradigm Insulin Infusion Pump (2014-03-17)April 14, 2014 · Medical devices · Medical devices · Type II
- Unicel DXH 600 and Unicel DXH 800 Coulter Cellular Analysis Systems (2014-03-06)April 14, 2014 · Medical devices · Medical devices · Type III
- Penadapt (2014-03-20)April 14, 2014 · Medical devices · Type II
- CT/MR Fletcher Set (2014-03-17)April 14, 2014 · Medical devices · Medical devices · Type II
- Progressa Bed Mattress (2014-03-19)April 14, 2014 · Medical devices · Medical devices · Type III
- Discovery MR750 and MR450 MR Systems and Optima MR450W MRI Systems (2014-03-28)April 14, 2014 · Medical devices · Medical devices · Type II
- Symbia T Series Gamma Camera/CT Scanners (2014-03-14)April 14, 2014 · Medical devices · Medical devices · Type II
- Sengstaken-Blakemore Tube 4-Lumen Suction (2014-03-12)April 14, 2014 · Medical devices · Medical devices · Type II
- Oticon Medical Healing Cap and Countertorque Wrench (2014-03-11)April 14, 2014 · Medical devices · Medical devices · Type III
- 1500T14 Cardiac Ablation System - Generator (2014-03-11)April 14, 2014 · Medical devices · Medical devices · Type II
- Peripheral and Flextome Cutting Balloons (2013-08-06)April 14, 2014 · Medical devices · Medical devices · Type III
- Ansell Sandel's Weighted Safety Scalpels (2013-12-19)April 14, 2014 · Medical devices · Medical devices · Type II
- EZ-LO 45 mm Needle Set (2014-04-01)April 14, 2014 · Medical devices · Medical devices · Type II
- Discovery MR750W 3.0T MRI System (2014-03-28)April 14, 2014 · Medical devices · Medical devices · Type II
- EnGen Laboratory Automation System (2014-03-21)April 14, 2014 · Medical devices · Medical devices · Type II
- Advia Centaur, Centaur CP, and Centaur XP Systems - Folate Assays (2014-03-26)April 14, 2014 · Medical devices · Medical devices · Type III
- Endo-Scrub2 - Sheath and Tubing Set (2014-03-13)April 14, 2014 · Medical devices · Medical devices · Type III
- Steri-Vac Gas Sterillizer/Aerator (2014-03-17)April 14, 2014 · Medical devices · Medical devices · Type II
- Aerial Cushion (2014-02-13)April 14, 2014 · Medical devices · Medical devices · Type III
- Elecsys HIV Combi PT (2014-01-29)April 14, 2014 · Medical devices · Medical devices · Type III
- Amplatzer Septal Occluder - Risk of Erosion - For Health ProfessionalsApril 14, 2014 · Medical devices · Product safety
- Amplatzer Septal Occluder - Risk of Erosion - For the PublicApril 14, 2014 · Medical devices · Product safety
- Synchromed II - Programmable Pump (2014-03-05)April 14, 2014 · Medical devices · Medical devices · Type II
- Bionic Comfortline Chair (2014-03-24)April 14, 2014 · Medical devices · Medical devices · Type II
- Digital Diagnost (2014-03-20)April 14, 2014 · Medical devices · Medical devices · Type II
- Etest Ertapenem Foam ETP 32 (2014-02-17)April 14, 2014 · Medical devices · Medical devices · Type III
- Discovery MR750 and MR450 1.5T MR System, and Optima MR450W MRI System (2014-04-12)April 12, 2014 · Medical devices · Medical devices · Type II
- STRL MIS and Sterile Gyne laparoscopy kit, and Ensemble STR POUR Arthroscopie (2014-04-10)April 10, 2014 · Medical devices · Medical devices · Type II
- Accu-Chek Mobile test cassette and test strips (2014-04-08)April 8, 2014 · Medical devices · Medical devices · Type II
- E. Coli H Pool A-F Antisera (2014-01-15)April 7, 2014 · Medical devices · Medical devices · Type III
- Endowel (2014-02-26)April 7, 2014 · Medical devices · Medical devices · Type II
- Kodak 2100 and 2200 Intraoral X-Ray System (2014-03-03)April 4, 2014 · Medical devices · Medical devices · Type II
- AccuMax Quantum VPC Pressure Redistribution System (2013-05-20)April 4, 2014 · Medical devices · Medical devices · Type II
- Coiled Tube Infusor (2014-03-05)April 4, 2014 · Medical devices · Medical devices · Type II
- iMRS (2014-03-19)April 4, 2014 · Medical devices · Medical devices · Type III
- Intellispace Portals - DX and HX (2014-03-11)April 4, 2014 · Medical devices · Medical devices · Type II
- Sway Balance Software Application (2014-01-27)April 4, 2014 · Medical devices · Medical devices · Type III
- Hotline Fluid Warming Sets (2013-03-14)April 4, 2014 · Medical devices · Medical devices · Type II
- Axiom Vertix MD Trauma (2014-03-05)April 4, 2014 · Medical devices · Medical devices · Type II
- Otoclear Ear Irrigation System (2014-02-21)April 4, 2014 · Medical devices · Medical devices · Type II
- Vector TAS Kit and Vector Modular Driver (2011-11-30)April 4, 2014 · Medical devices · Type II
- Zym B Reagent, API NH Strip, API Listeria, and FB Reagent (2014-03-07)April 4, 2014 · Medical devices · Listeria - Medical devices · Type II
- Vitek MS-CHCA Matrix and Vitek MS-DS Target Slides (2014-02-27)April 4, 2014 · Medical devices · Medical devices · Type III
- Lapidus Plate (2014-02-26)April 4, 2014 · Medical devices · Medical devices · Type II
- Plackers Dental Tools (2013-12-05)April 4, 2014 · Medical devices · Medical devices · Type III
- Antimicrobial Susceptibility Discs (2014-03-12)April 4, 2014 · Medical devices · Medical devices · Type III
- Leuko-Trol Platelet Control Cells (2014-03-12)April 4, 2014 · Medical devices · Medical devices · Type III
- Vertex Epic Camera / Pegasys Ultra Imaging (2014-03-07)April 4, 2014 · Medical devices · Medical devices · Type II
- Allset+T Gold HLA ABC Low Resolution (2014-03-11)April 4, 2014 · Medical devices · Medical devices · Type III
- Intesys Clinical Suite (ICS) G2 Full/Smart Disclosure (2014-03-07)April 4, 2014 · Medical devices · Medical devices · Type III
- Knee Nozzle (2014-01-23)April 4, 2014 · Medical devices · Medical devices · Type III
- NucliSENS Easymag Lysis Buffer (2014-03-06)April 4, 2014 · Medical devices · Medical devices · Type II
- Locator Implant Attachment (2014-01-16)April 4, 2014 · Medical devices · Medical devices · Type III
- Omnilab Version 12 (2014-03-06)April 4, 2014 · Medical devices · Medical devices · Type II
- Quanta Lite h-tTG IgG Elisa (2014-02-17)April 4, 2014 · Medical devices · Medical devices · Type III
- Trabecular Metal Total Ankle - Talar and Tibial Base (2013-11-14)April 4, 2014 · Medical devices · Medical devices · Type II
- Hospira Receptal 1 Litre Canister and 1 Litre Liner, an accessory to the Laerdal Suction Unit (2013-05-27)April 4, 2014 · Medical devices · Medical devices · Type II
- Compoglass F Cavifil (2014-02-12)April 4, 2014 · Medical devices · Medical devices · Type III
- Hintegra Tibial and Talar Implants and Revision Components (2014-02-25)April 4, 2014 · Medical devices · Medical devices · Type II
- Acuson P300 (2014-03-12)April 4, 2014 · Medical devices · Medical devices · Type II
- Advia Centaur, Centaur CP, and Centaur XP Systems - Procaclitonin Assay (PCT) (2014-02-21)April 4, 2014 · Medical devices · Medical devices · Type III
- Knee Pack,Ensemble Arthroscopie Genou and Arthoroscopy Pack (2014-04-03)April 3, 2014 · Medical devices · Medical devices · Type II
- Plum Lifecare 5000, Plum XL, and Plum XL 3 Infusion Systems and Plum XLM with Data Port (2014-01-27)March 27, 2014 · Medical devices · Medical devices · Type I
- Heartstart FR3 Defibrillator (2013-02-21)March 25, 2014 · Medical devices · Medical devices · Type II
- Allset Gold DPB1 High Resolution SSP and DPB1 SSP Unitray 12 Tests, DPB1 SSP Unitray with Taq 12 Test (2013-12-30)March 25, 2014 · Medical devices · Medical devices · Type III
- Heartstart MRX Defibrillator / Monitor (2014-02-26)March 25, 2014 · Medical devices · Medical devices · Type II
- Proceed Surgical Mesh (2014-02-21)March 25, 2014 · Medical devices · Medical devices · Type II
- Allset Gold SSP HLA Direct to High Resolution Kit and SSP Unitray - High Resuloution Class II (2013-07-10)March 25, 2014 · Medical devices · Medical devices · Type III
- StaRRsed Inversa 24M (2014-03-05)March 25, 2014 · Medical devices · Medical devices · Type II
- Oxoid Legionella Pneumophila 2-14 Reagent (2014-02-07)March 25, 2014 · Medical devices · Medical devices · Type III
- Infinity Acute Care System Workstation (2014-02-24)March 25, 2014 · Medical devices · Medical devices · Type II
- Heartstart MRX Defibrillator / Monitor and QCPR-CPR Meter Upgrade Kit (2014-02-26)March 25, 2014 · Medical devices · Medical devices · Type II
- Acu-Loc 2 VDR Proximal T- Guide (2014-02-07)March 25, 2014 · Medical devices · Medical devices · Type II
- Peristeen Anal Irrigation System, Catheter and Irrigation Accessory Unit (2014-01-15)March 25, 2014 · Medical devices · Medical devices · Type III
- XVI and XVI R 4.5 (X-Ray Volume Imaging Systems), and XVI R 4.5 System - Upgrade Kit (2013-11-01)March 25, 2014 · Medical devices · Medical devices · Type II
- Heartstart MRX Defibrillator / Monitor (2014-02-24)March 25, 2014 · Medical devices · Medical devices · Type II
- Plum A+ and Plum A+3 Infusion Pumps and HPL/RS Plug and Play Module (2014-02-25)March 25, 2014 · Medical devices · Medical devices · Type III
- Hand Control 12FR Suction Coagulator with 10 foot Cord and Holster, Sterile, Disposable (2014-02-27)March 25, 2014 · Medical devices · Medical devices · Type II
- XIO Radiation Treatment Planning System (2014-02-14)March 25, 2014 · Medical devices · Medical devices · Type II
- Cook 9 FR. Evolution Rl Dilator Sheath Set (2014-02-24)March 25, 2014 · Medical devices · Medical devices · Type III
- Hohmann Retractor (2014-02-14)March 25, 2014 · Medical devices · Medical devices · Type II
- SSP Unitray - High Resolution (2013-11-22)March 25, 2014 · Medical devices · Medical devices · Type III
- Samaritan Pad SAM 500P (2014-02-24)March 25, 2014 · Medical devices · Medical devices · Type II
- Homechoice Automated PD and Homechoice Automated PD Pro Systems (2014-03-03)March 25, 2014 · Medical devices · Medical devices · Type II
- Continuum MR Infusion System - Pump (2014-03-10)March 25, 2014 · Medical devices · Medical devices · Type I
- Altrus Thermal Tissue Fusion System - Handpiece (2014-02-28)March 25, 2014 · Medical devices · Medical devices · Type II
- Advia Centaur XP System - Class 2, 3, and 4 (2014-02-21)March 25, 2014 · Medical devices · Medical devices · Type III
- Elecsys AFP and Elecsys Total PSA (2014-02-17)March 25, 2014 · Medical devices · Medical devices · Type III
- Heartstart MRX Defibrillator / Monitor (2014-02-26)March 25, 2014 · Medical devices · Medical devices · Type II
- S-Rom Noiles Rotating Hinge Femur with Pin (2014-02-26)March 25, 2014 · Medical devices · Medical devices · Type II
- Heartmate II LVAS Implant Kit with Sealed Grafts (NAM and CE) and Heartmate II System Controller (NAM and CE) (2014-03-04)March 25, 2014 · Medical devices · Medical devices · Type I
- Omnipod Insulin Management System (2014-03-07)March 25, 2014 · Medical devices · Medical devices · Type I
- Heartstart MRX Defibrillator / Monitor-Battery / Power Module (2014-02-26)March 25, 2014 · Medical devices · Medical devices · Type II
- Triage Cardio3 Panel (2014-02-15)March 25, 2014 · Medical devices · Medical devices · Type II
- Medtronic Restore and PrimeAdvanced Neurostimulators (2014-02-18)March 25, 2014 · Medical devices · Medical devices · Type III
- Gemstar Pumps (2014-02-04)March 25, 2014 · Medical devices · Medical devices · Type II
- Advia Centaur and Advia Centaur XP Systems - Insulin Assays (2014-02-10)March 25, 2014 · Medical devices · Medical devices · Type III
- Phillips Heartstart HS1 Onsite Defibrillator (2014-02-21)March 25, 2014 · Medical devices · Medical devices · Type II
- Freestyle Blood Glucose Monitoring System and Freestyle Mini Blood Glucose Monitor (2014-02-21)March 25, 2014 · Medical devices · Medical devices · Type II
- Neuromuscular Transmission Module (2014-02-24)March 21, 2014 · Medical devices · Medical devices · Type II
- Premier Implant Scaler Universal (2014-02-21)March 21, 2014 · Medical devices · Medical devices · Type III
- Sigma Spectrum Infusion System with MDL (2014-02-10)March 21, 2014 · Medical devices · Medical devices · Type II
- Unicel DXH Slidemaker Stainer Coulter Cellular Analysis System (2014-02-07)March 21, 2014 · Medical devices · Medical devices · Type III
- Immage Low Concentration Immunoglobulin M (ILCIgM) (2014-02-10)March 21, 2014 · Medical devices · Medical devices · Type III
- Heartstart MRX Defibrillator / Monitor (2013-04-15)March 21, 2014 · Medical devices · Medical devices · Type II
- Kodak Directview DR 7500 Dual Detector System (using version 5 software) (2014-02-21)March 21, 2014 · Medical devices · Medical devices · Type II
- Heartstart XL (2014-02-21)March 21, 2014 · Medical devices · Medical devices · Type II
- Coulter Hematology Analyzers - LH 780 and LH 750 (2013-11-08)March 21, 2014 · Medical devices · Medical devices · Type I
- Artis Zee Floor (2014-02-07)March 21, 2014 · Medical devices · Medical devices · Type III
- Unicel DXH Slidemaker Stainer System (2014-02-06)March 21, 2014 · Medical devices · Medical devices · Type III
- Medtronic Spinal Cord Stimulation Therapy (2014-02-14)March 21, 2014 · Medical devices · Medical devices · Type II
- Syngo Dynamics - Server and Workstation Software (2014-02-20)March 21, 2014 · Medical devices · Medical devices · Type II
- Heartstart MRX Defibrillator/Monitor (2014-02-18)March 21, 2014 · Medical devices · Medical devices · Type II
- Immulite 2000 - Instrument Class 4 and Immulite 2000-2000 XPI Instrument (2014-02-10)March 21, 2014 · Medical devices · Medical devices · Type III
- Allset Gold and SSP Unitray low resolution kits (2013-10-22)March 20, 2014 · Medical devices · Medical devices · Type III
- Plegiox cardioplegia heat exchanger recall (2014-01-28)March 20, 2014 · Medical devices · Medical devices · Type III
- Arrow Edge and Nextstep Antegrade Hemodialysis Catheterization Sets (2014-02-07)March 20, 2014 · Medical devices · Medical devices · Type II
- Depuy CMW 2 Gentamicin Bone Cement (2014-02-06)March 20, 2014 · Medical devices · Medical devices · Type III
- Cardiac Catheterization Pack and By-pass Pack (2014-01-29)March 20, 2014 · Medical devices · Medical devices · Type II
- Advia Centaur, Advia Centaur CP, Advia Centaur XP Systems (2013-12-20)March 20, 2014 · Medical devices · Medical devices · Type III
- IDS-ISYS-Wash system (2014-01-24)March 20, 2014 · Medical devices · Medical devices · Type III
- Target 360 Ultra, Soft, Standard and Helical Ultra Detachable Coils (2013-07-15)March 20, 2014 · Medical devices · Medical devices · Type III
- Holding Forceps for Synream Reaming Rod (2014-02-06)March 20, 2014 · Medical devices · Medical devices · Type II
- Merit Maestro Microcatheter, Straight and Swan Neck (2013-12-05)March 20, 2014 · Medical devices · Medical devices · Type III
- I-stat 1 Analyzer system - G3+ Cartridge (2014-01-30)March 20, 2014 · Medical devices · Medical devices · Type II
- Dermalight 80 Psoracomb (2013-04-08)March 20, 2014 · Medical devices · Medical devices · Type II
- Labour and C-Section Delivery packs (2013-12-13)March 20, 2014 · Medical devices · Medical devices · Type III
- Cyberknife Robotic Radiosurgery System and Accuray XSight Spine Prone and Lung Package (2014-01-14)March 20, 2014 · Medical devices · Medical devices · Type II
- Viaflex container with connector (2013-11-26)March 20, 2014 · Medical devices · Medical devices · Type III
- OnLine DAT Amphetamines II (2014-02-06)March 20, 2014 · Medical devices · Medical devices · Type III
- Atreus 2 Component Integrated Processing Set (2014-02-04)March 20, 2014 · Medical devices · Medical devices · Type II
- Previ Isola (2014-01-31)March 19, 2014 · Medical devices · Medical devices · Type II
- Cognis Cardiac Defibrillators (N106 and N107) and Teligen Implantable Defibrillators (N102 and E110) (2013-08-29)March 19, 2014 · Medical devices · Medical devices · Type II
- Advia Chemistry Systems (2014-01-23)March 19, 2014 · Medical devices · Medical devices · Type III
- Novasure Radiofrequency Control Unit (2014-01-24)March 19, 2014 · Medical devices · Medical devices · Type III
- Cobas Polymerised Chain Reaction (PCR) Urine Kit (2013-12-06)March 18, 2014 · Medical devices · Medical devices · Type III
- Mckesson Horizon Medical Imaging (HMI) Products Version 4.6.1 to 11.6 (2013-09-09)March 18, 2014 · Medical devices · Medical devices · Type II
- NCL extension set and Nanoclave connector (2013-12-27)March 18, 2014 · Medical devices · Medical devices · Type II
- XIA 3 Torque Wrench (2014-01-14)March 18, 2014 · Medical devices · Medical devices · Type II
- Mosaic/Hancock II Ultra Supra Sizer and Mosaic Obturator (2014-01-10)March 18, 2014 · Medical devices · Medical devices · Type II
- Slideprep Plus Cytology Centrifuge (2013-06-10)March 18, 2014 · Medical devices · Medical devices · Type II
- Colleague Single Channel CXE Pump, French (2014-02-04)March 18, 2014 · Medical devices · Medical devices · Type II
- Cobas B221 - Reference Electrode (2014-01-31)March 18, 2014 · Medical devices · Medical devices · Type I
- Axiom Artis DFC (2014-02-06)March 18, 2014 · Medical devices · Medical devices · Type II
- Streptex Latex Group F (2013-11-14)March 18, 2014 · Medical devices · Medical devices · Type III
- Synchron CX and LX Reagents (2014-01-29)March 18, 2014 · Medical devices · Medical devices · Type III
- Puritan Bennett Ventilators (2014-01-24)March 18, 2014 · Medical devices · Medical devices · Type II
- Peristeen Anal Irrigation System (2014-01-15)March 18, 2014 · Medical devices · Medical devices · Type III
- Coulter Body Fluid Control (2014-01-20)March 18, 2014 · Medical devices · Medical devices · Type III
- Testosterone Gen II Test Kit (2014-01-27)March 18, 2014 · Medical devices · Medical devices · Type III
- Dissecting Scissors 6.75 in (Sterile) (2014-01-28)March 18, 2014 · Medical devices · Medical devices · Type II
- Liaison EBV IgM Kit (2014-01-22)March 18, 2014 · Medical devices · Medical devices · Type II
- Smartsite Needleless Connector (2014-01-22)March 18, 2014 · Medical devices · Medical devices · Type II
- Sterile adapter for IS3000 model (2013-04-19)March 18, 2014 · Medical devices · Medical devices · Type II
- Teleflex ISIS HVT Tracheal Tube, Cuffed With Subg (2014-01-08)March 18, 2014 · Medical devices · Medical devices · Type II
- Todd Hewitt Broth with Gentamicin and Naladixic Acid (2014-01-14)March 18, 2014 · Medical devices · Medical devices · Type III
- Oncor Expression Digital Linear Accelerator (2014-01-23)March 18, 2014 · Medical devices · Medical devices · Type II
- Da Vinci Surgical Systems (2013-03-06)March 18, 2014 · Medical devices · Medical devices · Type II
- Antimicrobial Susceptibility Discs (2013-03-19)March 18, 2014 · Medical devices · Medical devices · Type III
- CPAP Boussignac (2014-01-20)March 18, 2014 · Medical devices · Medical devices · Type II
- Guide Wire (2014-01-24)March 18, 2014 · Medical devices · Medical devices · Type II
- System 1 Base 100/120v (2013-02-20)March 18, 2014 · Biologic or vaccine · Medical devices · Type II
- Large Needle and Mega Needle Drivers for Da Vinci systems (2013-11-15)March 18, 2014 · Medical devices · Medical devices · Type II
- MUX-100H System (2014-01-06)March 18, 2014 · Medical devices · Medical devices · Type II
- Exact Brand, Youth Power Toothbrush (2012-12-18)March 18, 2014 · Medical devices · Type II
- Horizon Medical Imaging Products (2013-12-23)March 18, 2014 · Medical devices · Medical devices · Type II
- TDHisto/Cyto Software (2013-12-09)March 18, 2014 · Medical devices · Medical devices · Type II
- Medi-Therm Hyper/Hyperthermia Machine (2014-02-06)March 18, 2014 · Medical devices · Medical devices · Type II
- DLP Elongated One Piece and Select 3D Arterial Cannula (2014-01-30)March 18, 2014 · Medical devices · Medical devices · Type II
- Vitros White Correction Factor Slides (2014-01-10)March 18, 2014 · Medical devices · Medical devices · Type II
- V Series Monitoring System (2014-01-27)March 18, 2014 · Medical devices · Medical devices · Type II
- Heartstart XL+ (2014-01-20)March 18, 2014 · Medical devices · Medical devices · Type III
- Lifecodes HLA-DRB1 Typing Kit (2014-01-29)March 18, 2014 · Medical devices · Medical devices · Type III
- Optima X-Ray Systems (2013-12-05)March 18, 2014 · Medical devices · Medical devices · Type III
- Gemstar Docking Station (2012-12-08)March 18, 2014 · Medical devices · Type II
- Encore 26 Advantage (2012-10-16)March 18, 2014 · Medical devices · Type III
- Neptune 2 Waste Management System - Rover (2014-01-24)March 18, 2014 · Medical devices · Medical devices · Type I
- Da Vinci Surgical System - IS3000 and Da Vinci SI System - Vision System Cart (2013-10-23)March 18, 2014 · Medical devices · Medical devices · Type II
- Vitros 25-OH Vitamin D Total Calibrator (2014-01-23)March 18, 2014 · Medical devices · Medical devices · Type II
- Trifurcated Extension Set (Standardbore Extension Set W/Bonded Maxplus Connector) (2014-01-17)March 18, 2014 · Medical devices · Medical devices · Type II
- Carbide Cutting Burrs (2013-12-19)March 18, 2014 · Medical devices · Medical devices · Type II
- Neuron Delivery Catheter 053 (2013-12-13)March 18, 2014 · Medical devices · Medical devices · Type III
- Unicel DXI 600 and DXI 800 Access Immunoassay Systems (2014-01-29)March 18, 2014 · Medical devices · Medical devices · Type III
- New Hospira infusion pumps still not available for sale: Company continues to address device issuesMarch 13, 2014 · Medical devices
- Abbott FreeStyle glucose test strips may produce false test results with certain devicesMarch 11, 2014 · Medical devices
- Rusch Bronchopart and Rusch Bronchopart White Bronchial Tubes (2014-03-04)March 4, 2014 · Medical devices · Medical devices · Type II
- Architect I system - Intact PTH Reagent Assay (2014-02-13)February 13, 2014 · Medical devices · Medical devices · Type II
- AU Chemistry Systems: ISE Cleaning Solution (2014-01-13)February 11, 2014 · Medical devices · Medical devices · Type II
- Acuvue Oasys Brand Contact Lenses for Presbyopia with Hydraclear Plus (2013-11-26)February 11, 2014 · Medical devices · Medical devices · Type III
- Teneo Dental Treatment Centre (2013-11-13)February 11, 2014 · Medical devices · Medical devices · Type II
- N'vision Application Card (2013-09-23)February 11, 2014 · Medical devices · Medical devices · Type II
- Amsco Evolution Steam Sterilizers (2013-10-18)February 11, 2014 · Medical devices · Medical devices · Type III
- Eightcheck 3WP X-TRA Control (2013-05-13)February 11, 2014 · Medical devices · Medical devices · Type III
- Oxoid Legionella BCYE Growth Supplement (2013-12-19)February 11, 2014 · Medical devices · Medical devices · Type III
- Dimension Vista System - Enzyme Calibrator (2014-01-20)February 11, 2014 · Medical devices · Medical devices · Type II
- Vitek 2, Vitek 2 Compact 30, and Vitek 2 Compact 60 system susceptibility test cards (2013-12-23)February 11, 2014 · Medical devices · Medical devices · Type III
- The Ivent 201 Disposable Breathing Patient Circuit (2014-01-13)February 11, 2014 · Medical devices · Medical devices · Type II
- Cobas PCR Female Swab Sample Kit and Cobas PCR Urine Kit (2013-12-06)February 11, 2014 · Medical devices · Medical devices · Type III
- Ariatele Telemetry Transmitter (2014-01-08)February 11, 2014 · Medical devices · Medical devices · Type II
- John Bunn Neb-U-Lite LX2 Nebulizer Compressor (2013-12-30)February 11, 2014 · Medical devices · Medical devices · Type III
- Xio Radiation Treatment Planning System (2013-12-20)February 11, 2014 · Medical devices · Medical devices · Type II
- Zoo Pack Fox Elastics (2014-01-03)February 11, 2014 · Medical devices · Medical devices · Type III
- Tytin Regular Set (2014-01-13)February 11, 2014 · Medical devices · Medical devices · Type III
- Immulite 2000 System - Osteocalcin Assay (2014-01-20)February 11, 2014 · Medical devices · Medical devices · Type III
- Peri-Guard, supple Peri-Guard, Vascu-Guard, and Dura-Guard (2013-11-21)February 11, 2014 · Medical devices · Medical devices · Type III
- Gambro Cartridge Blood Set - Blood Transport System For Hemodialysis (2013-12-11)February 11, 2014 · Medical devices · Medical devices · Type II
- Distalizer Jet Appliance Lock Nut (2014-01-03)February 11, 2014 · Medical devices · Medical devices · Type III
- Biotrin Control Parvovirus B19 IgM (2014-01-07)February 11, 2014 · Medical devices · Medical devices · Type III
- Simplexa Flu A/B and RSV Direct Assay (2014-01-10)February 11, 2014 · Medical devices · Medical devices · Type I
- Acuson SC2000 Ultrasound System (2014-01-10)February 11, 2014 · Medical devices · Medical devices · Type III
- Abbott Realtime High Risk HPV (2014-01-09)February 11, 2014 · Medical devices · Medical devices · Type II
- Patient Specific Instrument and Planning Kit - Orthognathic Kit (2013-11-08)February 11, 2014 · Medical devices · Medical devices · Type III
- Immulite 2000 System - Total IgE Assay (2013-12-27)February 11, 2014 · Medical devices · Medical devices · Type III
- Perceval S Post-Dilation Catheter (2013-01-14)February 10, 2014 · Medical devices · Medical devices · Type II
- Impax CV 7.8 SU3 - OCR Service for Pediatric Measurement Import (2013-09-30)February 10, 2014 · Medical devices · Medical devices · Type I
- Endo-Mate Insufflation Tubing and Insufflation Filter (2013-07-16)February 10, 2014 · Medical devices · Medical devices · Type II
- Zippie Voyage Early Intervention Device (Stroller)(2013-12-06)February 10, 2014 · Medical devices · Medical devices · Type II
- Hickman Subcutaneous Titanium Ports and Catheters (2014-01-07)February 10, 2014 · Medical devices · Medical devices · Type III
- PK7300 Automated Microplate System (2014-01-02)February 10, 2014 · Medical devices · Medical devices · Type III
- Hemolung RAS Cartridge Kit (2013-11-26)February 10, 2014 · Medical devices · Medical devices · Type II
- Micro SSP DNA Typing Trays (2013-02-21)February 10, 2014 · Medical devices · Medical devices · Type III
- Advia Centaur, Centaur CP, and Centaur XP (2013-12-30)February 10, 2014 · Medical devices · Medical devices · Type III
- Immulite Systems - Androstenedione Assay (2013-12-24)February 10, 2014 · Medical devices · Medical devices · Type III
- Vital Signs Adult Volume Ventilator Circuits and Heated Wire Respiratory Circuits (2013-12-25)February 10, 2014 · Medical devices · Medical devices · Type II
- Gemini TF Big Bore PET/CT Imaging System - Main Unit (2013-12-10)February 10, 2014 · Medical devices · Medical devices · Type II
- Single Use Twister Polyp Retrieval (2013-11-22)February 10, 2014 · Medical devices · Medical devices · Type II
- Fresenius Dialysate Machines (2013-11-13)February 10, 2014 · Medical devices · Medical devices · Type III
- Leica M525 F50 Surgical Microscopes (2013-11-18)February 10, 2014 · Medical devices · Medical devices · Type III
- Fresh Impression Brand Powder-Free Gloves (2013-10-17)February 10, 2014 · Medical devices · Medical devices · Type III
- Carestream Airlife Adult Inspiratory Line and Isothermal Custom Infant Respiratory Breathing Circuit (2013-05-29)February 10, 2014 · Medical devices · Medical devices · Type III
- Gyrus Bovie Electrosurgical Generators - Possible Fire Hazard - Notice to HospitalsFebruary 7, 2014 · Medical devices
- Weak D Cells (2013-12-13)February 3, 2014 · Medical devices · Medical devices · Type III
- Somatom Definition Systems (2013-12-10)February 3, 2014 · Medical devices · Medical devices · Type I
- Instrument Manager (2013-12-06)February 3, 2014 · Medical devices · Medical devices · Type I
- Lythos Digital Impression System (2013-11-25)February 3, 2014 · Medical devices · Medical devices · Type III
- Innova IGS 520 and IGS-540 Image Guided Systems (2013-08-09)February 3, 2014 · Medical devices · Medical devices · Type II
- Foot Control Panel Wireless (FCP Wl)(2013-08-22)February 3, 2014 · Medical devices · Medical devices · Type III
- Infinity Acute Care System (IACS) Monitoring Solution with C500 and C700 (2013-12-16)February 3, 2014 · Medical devices · Medical devices · Type III
- Dimension Vista System - Cyclosporine (CSA Assay) (2013-12-04)February 3, 2014 · Medical devices · Medical devices · Type II
- Imprint II Regular Body VPS Impression Material (2013-11-27)February 3, 2014 · Medical devices · Medical devices · Type III
- Giraffe and Panda Warmers and Giraffe T-Piece Infant Resuscitation System (2013-11-19)February 3, 2014 · Medical devices · Medical devices · Type II
- Dimension Vista TOBR and CRBM Flex Reagent Cartridges (2013-11-14)February 3, 2014 · Medical devices · Medical devices · Type III
- Platelet Concentrate Infusion Set and Lifeshield Plum and Lifeshield Plum Y-Type Blood Sets (2013-11-26)February 3, 2014 · Medical devices · Medical devices · Type II
- Carefusion - Safe-T Thoracentesis Tray - Drug Free (2013-08-27)February 3, 2014 · Medical devices · Medical devices · Type II
- Micro SSP High Resolution HLA Class II DNA Typing Trays (2013-11-04)February 3, 2014 · Medical devices · Medical devices · Type III
- Remipack (2013-12-12)February 3, 2014 · Medical devices · Medical devices · Type I
- R100 Ventilator System (2013-11-15)February 3, 2014 · Medical devices · Type II
- Kodak Directview DR 7500 System and DRX-Evolution Systems (2013-12-02)February 3, 2014 · Medical devices · Medical devices · Type II
- Proteus XR/A General Purpose Radiographic System and Precision 500D System (2014-01-27)January 27, 2014 · Medical devices · Medical devices · Type III
- Tracoe Twist Tracheostomy and Laryngectomy Tubes (2013-07-19)January 27, 2014 · Medical devices · Medical devices · Type II
- Piccolo Lipid Panel and Piccolo Lipid Panel Plus (2013-12-11)January 24, 2014 · Medical devices · Medical devices · Type III
- Weck Electrosurgical Coagulation Suction Tube (2013-12-18)January 24, 2014 · Medical devices · Medical devices · Type II
- Brilliance CT Big Bore System - Main Unit (2013-12-19)January 24, 2014 · Medical devices · Medical devices · Type III
- Unicel DXH 600 Coulter and DXH 800 Coulter Cellular Analysis Systems (2013-12-23)January 24, 2014 · Medical devices · Medical devices · Type III
- Dimension Reaction Vessels (2013-12-19)January 24, 2014 · Medical devices · Medical devices · Type III
- Becton Dickinson Interlink Threaded Lock Cannula, 15g (2013-11-26)January 24, 2014 · Medical devices · Medical devices · Type II
- Brightview Gamma, XCT, and X Camera Systems (2013-12-24)January 24, 2014 · Medical devices · Medical devices · Type II
- Essenta DR (2013-12-05)January 24, 2014 · Medical devices · Medical devices · Type II
- Advantx, Prestilix, Prestige, and Precision Systems (2013-11-11)January 24, 2014 · Medical devices · Medical devices · Type III
- A-642100 Fixed Offset Adapter (2013-10-25)January 24, 2014 · Medical devices · Medical devices · Type II
- Resuscitation Units - Giraffe Warmer, Panada Warmer and T-Piece (2013-12-13)January 24, 2014 · Medical devices · Medical devices · Type II
- Gastroccult Test for Gastric Occult Blood and pH (2013-12-13)January 24, 2014 · Medical devices · Medical devices · Type III
- Inzii 12/15 mm Retrieval System (2013-10-23)January 24, 2014 · Medical devices · Medical devices · Type III
- ABX Pentra 400 Clinical Chemistry System - Controls (2013-12-05)January 24, 2014 · Medical devices · Medical devices · Type III
- Bioflash System Rinse (2014-01-10)January 24, 2014 · Medical devices · Medical devices · Type III
- System 1 Express Quick Connect (QFC1716INT) (2013-12-18)January 24, 2014 · Medical devices · Medical devices · Type III
- Ingenia 1.5T (2013-12-10)January 24, 2014 · Medical devices · Medical devices · Type III
- Softbank II (2013-11-11)January 24, 2014 · Medical devices · Medical devices · Type II
- Sterrad 100NX, Sterrad 100S, Sterrad 50 and Sterrad NX Sterilizers (2013-12-11)January 24, 2014 · Medical devices · Medical devices · Type III
- Streptex Latex Agglutination Kit (2013-05-06)January 24, 2014 · Medical devices · Medical devices · Type III
- Handicare Hygiene Highback Sling (2013-10-03)January 24, 2014 · Medical devices · Medical devices · Type II
- Avatar SC-5 (2013-05-20)January 24, 2014 · Medical devices · Medical devices · Type III
- Segmental System,Polyethylene Inserts, B and C (2013-12-27)January 17, 2014 · Medical devices · Medical devices · Type II
- Advia 1650 Chemistry System Analyzer and Advia 1200 Chemistry System Instrument (2013-12-19)January 17, 2014 · Medical devices · Medical devices · Type II
- D-10 Haemoglobin Testing System - Dual Program (HBA2/E/AIC) (2013-12-19)January 17, 2014 · Medical devices · Medical devices · Type III
- Gemini TF (16, 64, and Big Bore) PET/CT Systems - Main Units (2013-12-09)January 17, 2014 · Medical devices · Medical devices · Type II
- Patient Specific Instrument and Planning Kit - Orthognathic Kit, Two Splints (2013-11-08)January 17, 2014 · Medical devices · Medical devices · Type III
- Stiff 25 GA Wide Field Endo Illuminator, 23 GA Chandelier Infusion Cannula, and 25 GA AWH Vivid Chandelier (2013-12-06)January 17, 2014 · Medical devices · Medical devices · Type II
- Oncor Expression, Oncor Impression and Artiste MV Linear Accelerators (2013-12-06)January 17, 2014 · Medical devices · Medical devices · Type III
- Hemochron Jr. Citrate APTT Test Cuvette (2013-12-20)January 17, 2014 · Medical devices · Medical devices · Type II
- LP(A) SPQ II Reagent Set (2013-12-18)January 17, 2014 · Medical devices · Medical devices · Type II
- Hamilton - C2 Ventilator (2013-11-25)January 17, 2014 · Medical devices · Medical devices · Type III
- Becton Dickinson Bactec FX System, Bottom (2013-12-10)January 16, 2014 · Medical devices · Medical devices · Type II
- Blood glucose meter recalled: May give out wrong blood sugar levelsJanuary 14, 2014 · Medical devices · Product safety
- ETHYLMYTHACRYLATE DENTURE RESINS (2014-01-13)January 13, 2014 · Medical devices · Medical devices · Type II
- 15 L Cycler Drainage Bag (2013-12-04)January 13, 2014 · Medical devices · Medical devices · Type III
- Veris 8600 Vital Signs Monitor - Systems (2013-11-20)January 13, 2014 · Medical devices · Medical devices · Type I
- Beckman Coulter Cell Preparation System FP1000 (2013-11-25)January 13, 2014 · Medical devices · Medical devices · Type III
- CSF-Unitized Shunt, Contoured Regular, Low Pressure and Medium Pressure (2013-11-19)January 13, 2014 · Medical devices · Medical devices · Type III
- Lipid Panel Plus Reagent Disc (Part Number 400-0030) (2013-10-23)January 13, 2014 · Medical devices · Medical devices · Type III
- Stryker S3 Med/Surg and Secure II Medical / Surgical Beds (2013-11-29)January 13, 2014 · Medical devices · Medical devices · Type III
- CUSA Excel Plus System Nosecones (2013-12-06)January 13, 2014 · Medical devices · Medical devices · Type II
- Puritan Bennett Ventilator 840 (2013-12-06)January 13, 2014 · Medical devices · Medical devices · Type II
- ZYM B Reagent and API Biomedical Tests (2013-11-12)January 13, 2014 · Medical devices · Medical devices · Type II
- Discovery PET/CT 600 and 690 Systems - Main Units (2013-12-06)January 13, 2014 · Medical devices · Medical devices · Type II
- Aria Radiation Oncology Software (Version 6.5) and Eclipse Treatment Planning System (2013-11-18)January 13, 2014 · Medical devices · Medical devices · Type II
- Herculite Ultra Nozzle Tips (2013-11-26)January 13, 2014 · Medical devices · Medical devices · Type III
- Omnipro-Accept (2013-08-07)January 6, 2014 · Medical devices · Medical devices · Type II
- Mach 4 Universal HRP Polymer Kit With DAB (2013-11-20)January 6, 2014 · Medical devices · Medical devices · Type III
- Sysmex Blood Analyzers (2013-11-22)January 6, 2014 · Medical devices · Medical devices · Type II
- Discovery PET/CT 710 System (2013-11-22)January 6, 2014 · Medical devices · Medical devices · Type II
- Triage Cardio3 Panel (2013-11-11)January 6, 2014 · Medical devices · Medical devices · Type II
- Dimension Systems Reagent Cartridges (2013-11-20)January 6, 2014 · Medical devices · Medical devices · Type III
- HP M.B.T. Keel Punch Knee Instrument (2013-11-20)January 6, 2014 · Medical devices · Medical devices · Type II
- Orchestra and Orchestra Plus Programmers (2013-11-21)January 6, 2014 · Medical devices · Medical devices · Type II
- Navigation Compatible Accolade Broach Handle (2013-11-26)January 6, 2014 · Medical devices · Medical devices · Type II
- Patient Side Manipulators on the Da Vinci S, SI, and SI-E Patient Side Cart (2013-11-11)January 6, 2014 · Medical devices · Medical devices · Type II
- Triage Troponin I Test (2013-11-11)January 6, 2014 · Medical devices · Medical devices · Type II
- Patient Data Module (2013-11-11)January 6, 2014 · Medical devices · Medical devices · Type II
- Immage Immunochemistry System (2013-08-19)January 6, 2014 · Medical devices · Medical devices · Type III
- Patient Data Module (2013-11-11)January 6, 2014 · Medical devices · Medical devices · Type II
- Disposable Gas Sampling Lines (2013-11-19)January 6, 2014 · Medical devices · Medical devices · Type II
- Medfusion 4000 (2013-11-25)January 6, 2014 · Medical devices · Medical devices · Type II
- Ocean Blood Recovery Systems (2013-11-22)January 6, 2014 · Medical devices · Medical devices · Type II
- Truetrack Blood Glucose Meter (2013-10-15)January 6, 2014 · Medical devices · Medical devices · Type I
- Weighted Safety Scalpel Blade Sterile (2013-11-13)January 6, 2014 · Medical devices · Medical devices · Type II
- Statstrip Meter System and Statsensor Creatinine Hospital Meter Kit (2013-11-22)January 6, 2014 · Medical devices · Medical devices · Type III
- Delivery Catheter System with Accutrak Stability Layer (2013-11-21)January 6, 2014 · Medical devices · Medical devices · Type I
- Calcium Alginate Fiber Tipped Wood (2013-06-04)January 6, 2014 · Medical devices · Medical devices · Type III
- Camino Advanced Monitor (2013-11-27)January 6, 2014 · Medical devices · Medical devices · Type III
- Synchron Systems Reagents (2013-11-15)January 6, 2014 · Medical devices · Medical devices · Type III
- SEAC Dental System - Model 2020 (2013-11-19)January 6, 2014 · Medical devices · Medical devices · Type III
- Floseal Hemostatic Matrix (2013-11-12)January 6, 2014 · Medical devices · Medical devices · Type II
- Dimension Vista Systems Aliquot Plates (2013-10-30)January 6, 2014 · Medical devices · Medical devices · Type III