Health product recalls and alerts, 2018
929 notices, newest first. Each links to the official notice.
Drugs, vaccines and biologics
- Briodine Solution (2018-12-27)December 27, 2018 · Veterinary drugs · Product safety · Type II
- Health Canada warns consumers that Pace, promoted as an alcohol substitute, is unauthorized and may pose serious health risksDecember 21, 2018 · Drugs · Unauthorized product
- One lot of Equate brand Lens Care System and Multi-Purpose Solution voluntarily recalled because of a labelling errorDecember 21, 2018 · Drugs · Labelling
- XARELTO (rivaroxaban) - Increase in all-cause mortality, thromboembolic and bleeding events in patients after transcatheter aortic valve replacementDecember 20, 2018 · Drugs · Product safety
- Health Canada releases test results of certain sartan drugsDecember 20, 2018 · Drugs
- Apo-Prednisone 5 mg Tablet (2018-12-18)December 18, 2018 · Drugs · Product safety · Type III
- Teva Canada Product Recall (2018-12-17)December 17, 2018 · Drugs · Product safety · Type II
- Foreign Product Alert: Quizz Capsules by Trio HealthcareDecember 14, 2018 · Drugs
- Acetaminophene - Liq 80mg/mL (2018-12-06)December 6, 2018 · Drugs · Product safety · Type I
- Acetaminophen Solution Oral Gtte 80 mg/mL USP (2018-12-06)December 6, 2018 · Drugs · Product safety · Type I
- PMS-Amoxicillin (2018-12-03)December 3, 2018 · Drugs · Product safety · Type III
- Health Canada reminds Canadians of dangers of Miracle Mineral Solution after investigation leads to guilty plea and two-year sentenceNovember 30, 2018 · Drugs
- Oxyvet 100 LP (2018-11-29)November 29, 2018 · Veterinary drugs · Product safety · Type II
- Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurityNovember 28, 2018 · Drugs · Product safety
- Mylan Pharmaceuticals Product Recall (2018-11-27)November 27, 2018 · Drugs · Product safety · Type II
- Summary Safety Review: Health Canada concludes that there are no new safety concerns with sunscreen productsNovember 26, 2018 · Drugs
- Bardon Management Product Recall (2018-11-26)November 26, 2018 · Drugs · Product safety · Type II
- Teva Canada Product Recall (2018-11-23)November 23, 2018 · Drugs · Product safety · Type III
- ACT-Candesartan 4mg tablets (2018-11-23)November 23, 2018 · Drugs · Product safety · Type III
- Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsulesNovember 22, 2018 · Drugs · Undeclared substance
- Foreign Product Alert: Black Lion Pill, Help 100% & Pure Natural & Body Slim capsules, Herba Saraf, Horny Little Devil, Ja Dera Max+ capsules, Lida (Plus) capsules, Nutra Organics Green Tea Extract capsules, Papapa, Red Zone Xtreme 3000, Rhino 69 Ext...November 22, 2018 · Drugs · Undeclared substance
- Acetaminophene Oral Sol for Children USP (2018-11-20)November 20, 2018 · Drugs · Product safety · Type I
- Nasacort Allergy 24hr (2018-11-19)November 19, 2018 · Drugs · Product safety · Type III
- Certain Option+ and Personelle sunscreens voluntarily recalled because of bacterial contaminationNovember 19, 2018 · Drugs · Contamination
- Unauthorized "21st Century DHEA" health product seized from Moose Jaw, SK, store is labelled to contain a controlled substance and may pose serious health risksNovember 16, 2018 · Drugs
- Several children's strawberry-flavoured acetaminophen syrups recalled because of defective child-resistant safety caps on the bottlesNovember 14, 2018 · Drugs · Labelling
- “Vita-X Revitalizing Capsules” for men may pose serious health risksNovember 14, 2018 · Drugs
- Acetaminophene - Liq 160mg / 5mL (2018-11-13)November 13, 2018 · Drugs · Product safety · Type I
- Acetaminophene Oral Sol for Children USP (2018-11-13)November 13, 2018 · Drugs · Product safety · Type I
- Air USP (2018-11-09)November 9, 2018 · Drugs · Product safety · Type III
- Shalina Diproson (2018-11-09)November 9, 2018 · Drugs · Product safety · Type II
- Mountain Equiment Co-op Product Recall (2018-11-09)November 9, 2018 · Drugs · Product safety · Type II
- XOFIGO® (radium Ra 223 dichloride) - Increased Incidence of Fractures and Trend for Increased Deaths with XOFIGO used in combination with abiraterone and prednisone/prednisoloneNovember 8, 2018 · Biologic or vaccine · Product safety
- Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety informationNovember 7, 2018 · Drugs · Labelling
- Mountain Equiment Co-op Product Recall (2018-11-06)November 6, 2018 · Drugs · Product safety · Type II
- Adrenalin Chloride Sol 1:1000 AMP (2018-10-26)October 26, 2018 · Drugs · Product safety · Type II
- Clinda-T Solution (2018-10-25)October 25, 2018 · Drugs · Product safety · Type II
- Vita Health Products Recall (2018-10-24)October 24, 2018 · Drugs · Product safety · Type II
- Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risksOctober 18, 2018 · Drugs · Unauthorized product
- Abiet Distributions Product Recall (2018-10-12)October 12, 2018 · Drugs · Product safety · Type II
- Osurnia gel (2018-10-04)October 4, 2018 · Drugs - Veterinary drugs · Product safety · Type II
- PMS-Solifenacin 5mg Tablet (2018-10-03)October 3, 2018 · Drugs · Product safety · Type II
- Health Canada finds Zhejiang Huahai Pharmaceuticals site non-compliant with requirements for the manufacture of drug ingredientsOctober 2, 2018 · Drugs
- Compliments Sunscreen Lotion 30 SPF Sport (2018-09-28)September 28, 2018 · Drugs · Product safety · Type II
- Empack Spraytech Product Recall (2018-09-28)September 28, 2018 · Drugs · Product safety · Type II
- EpiPen and EpiPen Jr auto-injectors may stick in their carrier tubeSeptember 28, 2018 · Drugs
- Health Canada reminds Canadians to consult a health professional before using high-concentration hydroquinone productsSeptember 25, 2018 · Drugs · Product safety
- Health Canada warns consumers to not use health products containing the potentially dangerous chemical DNPSeptember 20, 2018 · Drugs · Unauthorized product
- TECENTRIQ® (atezolizumab) - Risk of Immune-Related NephritisSeptember 18, 2018 · Biologic or vaccine · Product safety
- Taro-Tramadol 300mg Tablet (2018-09-17)September 17, 2018 · Drugs · Product safety · Type III
- Health Canada advises of a second impurity linked to recalled valsartan drugsSeptember 13, 2018 · Drugs
- Tromboject 1% and 3% (sodium tetradecyl sulfate) with Visible Particles - Update on the Use of Medical Grade FiltersSeptember 12, 2018 · Drugs · New safety information
- Overwaitea Acetaminophen 300mg with 15mg Caffeine & 8mg Codeine Phoshate Tablet (2018-09-11)September 11, 2018 · Drugs · Product safety · Type III
- Florinef 0.1mg Tablet (2018-09-11)September 11, 2018 · Drugs · Product safety · Type II
- Health Canada updates Canadians on estimates of health risks for recalled valsartan drugs containing NDMASeptember 10, 2018 · Drugs · New safety information
- Hydroval Ointment 0.2% (2018-09-05)September 5, 2018 · Drugs · Product safety · Type III
- Vita Health Products Recall (2018-08-29)August 29, 2018 · Drugs · Product safety · Type III
- Magnesium-45 0.5-4.5 (2018-08-29)August 29, 2018 · Drugs · Product safety
- EpiPen (epinephrine USP) Auto-Injector - Interim Order allowing the importation of AUVI-Q in response to shortages of EpiPen and EpiPen JrAugust 29, 2018 · Drugs · Product safety
- Drug and Alcohol Use During Orientation WeekAugust 20, 2018 · Drugs · Product safety
- Expansion of recall of valsartan drugs to include additional lots, as a precautionAugust 18, 2018 · Drugs · Product safety
- Teva Valsartan/HCTZ Product Recall (2018-08-17)August 17, 2018 · Drugs · Product safety · Type I
- FS Antimicrobial Hand Cleaner - 2.5% Liq (2018-08-16)August 16, 2018 · Drugs · Product safety · Type III
- Health Canada Warns Canadians of New Safety Information Related to Long-Term Use of Azithromycin Following Stem Cell Transplants in Cancer TreatmentAugust 13, 2018 · Drugs
- Kaolin Pectin Suspension (2018-08-11)August 11, 2018 · Veterinary drugs · Product safety · Type II
- PRO-Ciprofloxacin 250mg Tablet (2018-08-09)August 9, 2018 · Drugs · Product safety · Type II
- PMS-Ciprofloxacin 250mg Tablet (2018-08-08)August 8, 2018 · Drugs · Product safety · Type II
- Foquest Capsule (2018-08-08)August 8, 2018 · Drugs · Product safety · Type III
- Ayotai Canada Product Recall (Human Drugs) (2018-08-08)August 8, 2018 · Drugs · Product safety · Type II
- Contrave Tablet (Extended Release) (2018-08-06)August 6, 2018 · Drugs · Product safety · Type II
- Unauthorized skin creams and lotions sold at various retailers in Quebec may pose serious health risksAugust 1, 2018 · Drugs · Unauthorized product
- Health Canada updates Canadians on shortage situation involving EpiPen (0.3 mg) auto-injectorsJuly 30, 2018 · Drugs
- Adrenalin Chloride Sol 1:1000 AMP (2018-07-20)July 20, 2018 · Drugs · Product safety · Type II
- Tromboject 1% and 3% (sodium tetradecyl sulfate) with Visible ParticlesJuly 17, 2018 · Drugs · Product safety
- Yaz Plus Tablet (2018-07-12)July 12, 2018 · Drugs · Product safety · Type III
- Several drugs containing valsartan being recalled due to contamination with a potential carcinogenJuly 9, 2018 · Drugs
- Sivem Valsartan Product Recall (2018-07-09)July 9, 2018 · Drugs · Product safety · Type I
- Sandoz Valsartan Product Recall (2018-07-09)July 9, 2018 · Drugs · Product safety · Type I
- Pro Doc Valsartan Product Recall (2018-07-09)July 9, 2018 · Drugs · Product safety · Type I
- Sanis Valsartan Product Recall (2018-07-09)July 9, 2018 · Drugs · Product safety · Type I
- Teva Valsartan Product Recall (2018-07-09)July 9, 2018 · Drugs · Product safety · Type I
- Liberchem Product Recall (2018-07-04)July 4, 2018 · Veterinary drugs · Product safety · Type II
- Health Canada releases sunscreen testing resultsJune 28, 2018 · Drugs
- Drug Use During Festival SeasonJune 22, 2018 · Chemicals - Drugs · Product safety
- PropoVet Multidose 10mg/ml (2018-06-18)June 18, 2018 · Veterinary drugs · Product safety · Type III
- BLINCYTO (blinatumomab) and Benzyl Alcohol Toxicity for Pediatric PatientsJune 12, 2018 · Drugs · Product safety
- New safety information for women using dolutegravir, a medication used to treat HIV infectionJune 7, 2018 · Drugs · Product safety
- TIVICAY, TRIUMEQ and JULUCA (dolutegravir containing medicines) – Possible Risk of Neural Tube DefectsJune 7, 2018 · Drugs · Product safety
- Important sunscreen safety tips for CanadiansJune 1, 2018 · Drugs · Product safety
- Demulen 30 birth control pills: Packages containing broken or chipped pillsJune 1, 2018 · Drugs
- Sodium Chloride Injection USP (2018-06-01)June 1, 2018 · Drugs · Product safety · Type I
- Artista Brows by Micha Product Recall (2018-06-01)June 1, 2018 · Drugs · Product safety · Type II
- Rensow Product Recall (2018-06-01)June 1, 2018 · Drugs · Product safety · Type II
- Dextrose Injection USP (2018-06-01)June 1, 2018 · Drugs · Product safety · Type I
- Barbed Sutures and the Potential Risk of Small Bowel ObstructionMay 31, 2018 · Health products · Medical devices
- Pure Sun Defense Sunscreen SPF50 (2018-05-31)May 31, 2018 · Drugs · Product safety · Type III
- Xylocaine Jelly 2% (2017-12-18)May 28, 2018 · Drugs · Product safety · Type II
- Unauthorized Botox and other health products seized from Arshia Hair Salon and Spa in Toronto May Pose Serious Health RisksMay 19, 2018 · Drugs
- Unauthorized prescription antibiotic drugs seized from Gigi's Market in Ottawa, ON, may pose serious health risksMay 18, 2018 · Drugs
- Dextrose 5% Inj 5gm/100mL USP (2018-05-11)May 11, 2018 · Drugs · Product safety · Type I
- Sodium Chloride 0.9% Inj 900mg/100ml USP (2018-05-11)May 11, 2018 · Drugs · Product safety · Type I
- Hemorrhoidal Ointment (2018-05-09)May 9, 2018 · Drugs · Product safety · Type II
- Viibryd Starter Kit (10 & 20 mg)May 7, 2018 · Drugs · Product safety · Type II
- Erfa-Tranexamic 100 mg/mL (5 ml)May 3, 2018 · Drugs · Product safety · Type I
- Several GlaxoSmithKline Inc. vaccines: Potential Risk of UnderdosingMay 1, 2018 · Biologic or vaccine · Product safety
- Foreign Product Alert: 7 Days Slim hip & Legs caps, CA NI CAP Arm Slim, Perfect Slim by Peenuch capsules, Slim Perfect Legs, Ure Tonic Herbal TraditionalApril 30, 2018 · Drugs
- Adrenalin Chloride Sol 1:1000 AMP (2018-04-30)April 30, 2018 · Drugs · Product safety · Type II
- OraVerse Injection (2018-04-20)April 27, 2018 · Drugs · Product safety · Type III
- Erfa-Tranexamic 100 mg/mL (50mL)April 25, 2018 · Drugs · Product safety · Type I
- Bortezomib for Injection (2018-04-18)April 19, 2018 · Drugs · Product safety · Type I
- OvadineApril 18, 2018 · Veterinary drugs · Product safety · Type II
- Women taking birth control pills reminded to return any packages for replacement if the pills are missing or look unusualApril 16, 2018 · Drugs
- APO-AMOXI PWR FOR SUSP 125MG/5ML (2018-04-05)April 16, 2018 · Drugs · Type II
- Information Update - Shortage of EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injectors in CanadaApril 12, 2018 · Drugs
- Two lots of the epilepsy drug Primidone recalled because of high levels of lead, which may pose serious health risksApril 6, 2018 · Drugs
- Primidone TabletApril 5, 2018 · Drugs · Product safety · Type I
- Actogain 100 drug premix (2018-04-05)April 5, 2018 · Veterinary drugs · Product safety · Type III
- 0.9% Sodium Chloride Injection, 250 mL (2018-03-16)March 16, 2018 · Drugs · Product safety · Type I
- ZINBRYTA (daclizumab beta) - Voluntary Withdrawal in Canada due to Risk of EncephalitisMarch 16, 2018 · Biologic or vaccine · Product safety
- Health Canada to conduct review of a new potential safety risk of Fibristal (ulipristal acetate), a medication used to treat fibroidsMarch 15, 2018 · Drugs · Product safety
- Chipped pills in additional packages of Alysena 21 and 28 birth control pillsMarch 8, 2018 · Drugs
- Phenylbutazone powder (2018-03-02)March 2, 2018 · Veterinary drugs · Product safety · Type III
- Injectable products and unauthorized prescription drugs seized from Total Health Centre in Williams Lake, B.C.; products were being administered and sold by an individual posing as a naturopathic doctorMarch 2, 2018 · Drugs
- Shortage of Erwinase for Injection and Replacement with UK Labelled StockFebruary 27, 2018 · Biologic or vaccine · Product safety
- Lynparza® (2018-02-23)February 23, 2018 · Drugs · Product safety · Type III
- Ventolin Diskus: One lot recalled as inhalers may not deliver the intended doseFebruary 16, 2018 · Consumer products - Drugs
- VENTOLIN DISKUS (2018-02-16)February 16, 2018 · Drugs · Product safety · Type I
- TECENTRIQ (atezolizumab) - Risk of MyocarditisFebruary 14, 2018 · Biologic or vaccine
- Carbocaine 2% (2018-02-12)February 12, 2018 · Drugs · Product safety · Type I
- Alysena 28 birth control pill: One lot recalled due to chipped pills, which may reduce effectiveness in preventing pregnancyFebruary 9, 2018 · Drugs · Product quality
- Alysena 28 (2018-02-09)February 9, 2018 · Drugs · Product safety · Type I
- Drug and Alcohol Use During Spring BreakFebruary 5, 2018 · Drugs · Product safety
- Baxedin 2%-70% (2018-02-05)February 5, 2018 · Drugs · Product safety · Type III
- Hydromorphone hydrochloride injection USP (2018-01-31)January 31, 2018 · Drugs · Product safety · Type I
- Recall of Cannabis for Medical Purposes – AphriaJanuary 30, 2018 · Drugs · Labelling · Type III
- Shortage of EpiPen (0.3 mg) auto-injector in CanadaJanuary 18, 2018 · Drugs
- Baxter recalls one lot of DIANEAL peritoneal dialysis solution due to the potential presence of particulate matterJanuary 18, 2018 · Drugs
- Teva-Levocarbidopa (2018-01-17)January 17, 2018 · Drugs · Product safety · Type III
- DIANEAL PD4 CAPD SOLUTION WITH 1.5% DEXTROSE AND 2.5MEQ/L CALCIUM (2018-01-17)January 17, 2018 · Drugs · Product safety · Type I
- OFEV (nintedanib) - Risk of Drug-Induced Liver Injury and the Need for Regular Monitoring of Liver FunctionJanuary 11, 2018 · Drugs
- Day cream SPF 15, also sold in the kit named: Dry to Normal Skin Starter Kit (2017-12-20)January 3, 2018 · Drugs · Product safety · Type III
- Transdermal Nicotine Patch (2017-12-12)January 3, 2018 · Drugs · Product safety · Type III
Natural health products
- Jamp Pharma Product Recall (2018-12-20)December 20, 2018 · Natural health products · Product safety · Type II
- Health products manufactured by Professional Botanicals Inc. may pose serious health risksDecember 13, 2018 · Natural health products · Unauthorized product
- Unauthorized products may pose serious health risks (June 5, 2018 to November 7, 2018)December 7, 2018 · Natural health products
- Talc - Potential Risk of Lung Effects and Ovarian CancerDecember 5, 2018 · Beauty and personal care - Drugs - Natural health products · New safety information
- Human placenta products for consumption not authorized in Canada, may pose serious health risksNovember 27, 2018 · Natural health products
- Vita X Revitalizing Capsules (2018-11-13)November 13, 2018 · Natural health products · Product safety
- Operation Pangea XI reinforces the dangers of buying unauthorized health products onlineOctober 23, 2018 · Drugs - Natural health products - Medical devices
- Marvelon 28 birth control pills: Packages do not contain day-of-the-week stickersSeptember 11, 2018 · Drugs - Biologic or vaccine - Veterinary drugs - Natural health products - Medical devices
- Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contaminationSeptember 1, 2018 · Natural health products · Contamination
- Ecotrends Ecologics Products Recall (2018-08-30)August 30, 2018 · Natural health products · Product safety · Type II
- Several unauthorized products seized from Vitality Health Foods in Drayton Valley, AB, may pose serious health risksAugust 27, 2018 · Drugs - Natural health products · Unauthorized product
- Ayotai Canada Product Recall (NHPs) (2018-08-08)August 8, 2018 · Natural health products · Product safety · Type II
- "Jian Pai Natural Skin Care Cream" contains antifungal drugs not listed on the label, which may pose serious health risksAugust 2, 2018 · Drugs - Natural health products
- Genestra Brands AFA-Gen (2018-07-27)July 27, 2018 · Natural health products · Product safety · Type II
- Jian Pai Cream (2018-07-19)July 19, 2018 · Natural health products · Product safety · Type II
- Spirulina - Superaliment vert Powder (2018-07-18)July 18, 2018 · Natural health products · Product safety · Type II
- Actumus Regeneration 2 (2018-07-16)July 16, 2018 · Natural health products · Product safety · Type II
- MCP Powder (2018-06-25)June 25, 2018 · Natural health products · Product safety · Type III
- Jamp-Glucose 50 and Jamp-Glucose 75 – Risk of False Negative Oral Glucose Challenge or Tolerance Test ResultsJune 7, 2018 · Natural health products · Product safety
- Oragel Recall (2018-05-29)May 29, 2018 · Natural health products · Product safety · Type II
- Unauthorized products may pose serious health risks (November 17, 2017 to May 23, 2018)May 23, 2018 · Natural health products · Unauthorized product
- Mayinglong Shexiang Zhichuang Gao Ointment (2018-05-16)May 16, 2018 · Natural health products · Product safety · Type III
- Unauthorized "Sāj" kratom products seized from two Edmonton stores may pose serious health risksMay 4, 2018 · Natural health products
- One lot of Traditional Medicinals "Throat Coat Lemon Echinacea" herbal tea recalled because of potential contamination with SalmonellaApril 24, 2018 · Natural health products
- Bend Skincare Marine Collagen + Co-Factors (2018-04-12)April 19, 2018 · Natural health products · Product safety · Type III
- "Organic Traditions Shatavari Powder" sold at Choices Markets Yaletown in Vancouver, B.C., contaminated with SalmonellaApril 6, 2018 · Natural health products
- Evanhealy Blemish Face Care Kit (2018-02-28)April 3, 2018 · Natural health products · Product safety · Type II
- Plant Devas Inc. recalls Lemongrass Facial Polish and evanhealy Clays sold individually and as a part of evanhealy Face Care KitsApril 3, 2018 · Beauty and personal care - Natural health products
- Shatavari PowderMarch 29, 2018 · Natural health products · Type I
- "Beyond Yourself Multi Athlete" and unauthorized bulk "Multi-Vitamines" seized from Shop Santé stores in Quebec may pose serious health risksMarch 16, 2018 · Natural health products
- Sexual enhancement product "Leopard Miracle of Honey" may pose serious health risksMarch 14, 2018 · Drugs - Natural health products
- Sisu Inc. voluntarily recalls numerous natural health products because the glass bottles may contain glass fragmentsFebruary 22, 2018 · Natural health products · Labelling - Product quality
- Sisu Natural Health Products (2018-02-09)February 9, 2018 · Natural health products · Product safety · Type II
- Unauthorized kratom and sexual enhancement products seized from multiple George's Convenience stores in the Greater Toronto Area may pose serious health risksJanuary 25, 2018 · Natural health products
- Foreign Product Alert: Adipessum Miracle Slimming Capsules, Beautiful Lose Weight, Blue Pearl All Natural Male Enhancement pill, Chong Cao Dan pills, Fruta Planta Life capsules, Hard Rod Plus capsules, Hard Times for Men capsule, Linsen Double Caulis...January 17, 2018 · Natural health products
- Flintstones Plus Iron multivitamins for children: One bottle found to contain unidentified capsules instead of chewable tabletsJanuary 12, 2018 · Natural health products
- Paklx - MATCH IT! Platelet Antibody Software (V1.1) (2017-09-29)January 11, 2018 · Natural health products · Medical devices · Type II
- Eyesaline Eyewash (2018-01-09)January 9, 2018 · Natural health products · Product safety · Type II
- Ultrapure Colloidal Silver 20+ ppm (2018-01-02)January 2, 2018 · Natural health products · Product safety · Type II
Medical devices
- fabian Therapy evolution (2018-12-17)December 28, 2018 · Medical devices · Medical devices · Type I
- Fabian HFO and fabian Therapy evolution (2018-12-18)December 28, 2018 · Medical devices · Medical devices · Type I
- DRAEGERWERK AG & CO. KGAA's Disposable Breathing Circuits (2018-12-23)December 27, 2018 · Medical devices · Medical devices · Type I
- DUREX RealFeel 20 ct condoms (2018-12-26)December 27, 2018 · Medical devices · Medical devices · Type II
- U by Kotex Sleek Unscented Menstrual Tampons, Regular AbsorbencyDecember 13, 2018 · Medical devices · Type II
- EDS Light Suspensions, Central Axis (2018-11-21)December 10, 2018 · Medical devices · Medical devices · Type II
- Reliance Blunt Probe (2018-11-19)December 10, 2018 · Medical devices · Medical devices · Type II
- Kit COBAS 6800/8800 HCV 96T CE-IVD (2018-11-19)December 10, 2018 · Medical devices · Medical devices · Type III
- enVista One Piece Hydrophobic Acrylic IOL (2018-11-08)December 10, 2018 · Medical devices · Medical devices · Type II
- T34 Ambulatory Syringe Pump (2018-11-26)December 10, 2018 · Biologic or vaccine - Medical devices · Medical devices · Type II
- Sonicare Toothbrush, EasyClean (2018-11-25)December 10, 2018 · Medical devices · Medical devices · Type III
- Sysmex Urine Quality Control and Calibrator (2018-11-19)December 10, 2018 · Medical devices · Medical devices · Type III
- Hydra Vision Urology System and Direct Digital Imaging System (2018-10-07)December 10, 2018 · Medical devices · Medical devices · Type II
- Elecsys Anti-HAV (2018-11-18)December 10, 2018 · Medical devices · Medical devices · Type III
- Transpac IV Monitoring Kit with Safeset Reservoir and Blood Sampling Port (2018-11-18)December 10, 2018 · Medical devices · Medical devices · Type II
- CgA-ELISA and ALDO-RIACT (2018-11-22)December 10, 2018 · Medical devices · Medical devices · Type II
- Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter (2018-11-12)December 10, 2018 · Medical devices · Medical devices · Type III
- BioPlex 2200 EBV IgM Control Set (2018-11-21)December 10, 2018 · Medical devices · Medical devices · Type II
- Interactive Precision IO Scan Adapter (2018-11-25)December 10, 2018 · Medical devices · Medical devices · Type III
- D-100 HBA1C Hemoglobin Testing System (2018-11-05)December 10, 2018 · Medical devices · Medical devices · Type II
- Alpen Carbide 702 Cross Cut Tapered Fissure FG lOpk (Carbide burs) (2018-04-18)November 30, 2018 · Medical devices · Medical devices · Type III
- SQ-RX Pulse Generator (2018-11-05)November 30, 2018 · Medical devices · Medical devices · Type II
- Stopcocks Clear, Four-Way Stopcock, Double Luer Lock Adapter, and Stopcock, Clear 1-Way w/ Male Luer Lock (2018-11-04)November 30, 2018 · Medical devices · Medical devices · Type II
- Staclot LA (2018-11-12)November 30, 2018 · Medical devices · Medical devices · Type III
- Advanced Perfusion System 1 - EPGS Service Manual (2018-11-10)November 30, 2018 · Medical devices · Medical devices · Type III
- Regeneross Resorbable xenograft porcine anorganic bone mineral (2018-11-06)November 30, 2018 · Medical devices · Medical devices · Type III
- Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer (2018-11-12)November 30, 2018 · Biologic or vaccine - Medical devices · Medical devices · Type III
- Signa HDe 1.5T MRI System and Signa Explorer (2018-11-19)November 30, 2018 · Medical devices · Medical devices · Type II
- Medex High Pressure Stopcocks (2018-11-18)November 30, 2018 · Medical devices · Medical devices · Type II
- SmartClip SL3 Self-Ligating Appliance System with APC II Adhesive Coated Appliance System (2018-11-13)November 30, 2018 · Medical devices · Medical devices · Type II
- Elecsys FT4 III (2018-10-05)November 30, 2018 · Medical devices · Medical devices · Type II
- SYNGO.PLAZA (2018-11-11)November 30, 2018 · Medical devices · Medical devices · Type III
- Optima MR360 1.5T (2018-11-19)November 30, 2018 · Medical devices · Medical devices · Type II
- Signa Horizon LX Magnetic Resonance System, Signa Infinity 1.5T TwinSpeed Excite MR System, Signa HDxt 1.5T and 3.0T MR System (2018-11-19)November 30, 2018 · Medical devices · Medical devices · Type II
- CWP 800 (Central Water Plant) Systems (2018-11-14)November 30, 2018 · Medical devices · Medical devices · Type III
- MagNA Pure 24 Instrument (2018-10-13)November 30, 2018 · Medical devices · Medical devices · Type III
- RayStation (2018-11-10)November 30, 2018 · Medical devices · Medical devices · Type III
- Mio Care Pro, Mio Care Beauty, Mio Vein, Mio Peristim, Smart TENS, Mio Care Fitness, Mio Sonic, Orthomag, and Mag 2000 Plus (2018-10-18)November 30, 2018 · Biologic or vaccine - Medical devices · Medical devices · Type II
- Sysmex XN-10 Hematology analyzer (2018-11-12)November 30, 2018 · Medical devices · Medical devices · Type III
- Centricity Universal Viewer Zero Footprint Client (2018-11-08)November 30, 2018 · Medical devices · Medical devices · Type II
- Various Olympus Medical Systems Corp.'s Bronchofibervideoscope, Bronchofiberscope and Laryngoscope products (2018-09-26)November 30, 2018 · Medical devices · Medical devices · Type II
- Heart Lung Pack and Cardiovascular Oxygentor Packs (2018-11-07)November 30, 2018 · Medical devices · Medical devices · Type II
- RapidFlap System, 12MM - 20MM RapidFlap SpinDown Clamp (2018-10-11)November 30, 2018 · Medical devices · Medical devices · Type II
- HeartStart MRX Rechargeable Lithium Ion Battery (2018-10-27)November 30, 2018 · Medical devices · Medical devices · Type II
- SONIMAGE HS1 Ultrasound System Customer (2017-12-02)November 30, 2018 · Medical devices · Medical devices · Type III
- Xper Flex Cardio Physiomonitoring System-Main Unit (2018-11-18)November 30, 2018 · Medical devices · Medical devices · Type II
- THERMOCOOL SMARTTOUCH SF Uni-Directional and Bi-Directional Navigation Catheter (2018-10-20)November 28, 2018 · Medical devices · Medical devices · Type II
- ITS4850A IntelliVue Telemetry System - MONITOR (2018-11-11)November 28, 2018 · Medical devices · Medical devices · Type III
- Salem Sump Dual Lumen Stomach Tubes (2018-11-05)November 28, 2018 · Medical devices · Medical devices · Type II
- SHOEBOX Audiometry Pro (2018-11-06)November 28, 2018 · Medical devices · Medical devices · Type III
- Uresta Bladder Support (2018-11-04)November 28, 2018 · Medical devices · Medical devices · Type II
- Sapphire Epidural Set Yellow-Striped Microbore (2018-11-04)November 28, 2018 · Medical devices · Medical devices · Type II
- Electronic O2 Blender/Analyzer (2018-11-11)November 28, 2018 · Medical devices · Medical devices · Type II
- RadPRO Mobile 3 40kW (2018-11-02)November 28, 2018 · Medical devices · Medical devices · Type II
- s5i Imaging System (2018-11-08)November 28, 2018 · Medical devices · Medical devices · Type III
- PreciseType HEA Molecular BeadChip Test and RHD Molecular BeadChip Test (2018-10-30)November 28, 2018 · Medical devices · Medical devices · Type II
- Brilliance 40/60 Slice CT System, 6/10/16 Slice CT System, and CT System (16P) (2018-10-23)November 28, 2018 · Medical devices · Medical devices · Type II
- Autovac Biopsy Needle (2018-11-04)November 28, 2018 · Medical devices · Medical devices · Type III
- DELFIA Xpress (2018-11-01)November 28, 2018 · Medical devices · Medical devices · Type III
- L25 Needle Guide Bracket (2018-11-01)November 28, 2018 · Medical devices · Medical devices · Type II
- StrataMR Adjustment Tools and StrataMR Guider Tool (2018-10-25)November 28, 2018 · Medical devices · Medical devices · Type II
- Medline Adhesive Bandage (2018-10-25)November 28, 2018 · Medical devices · Medical devices · Type II
- M/DN Intramedullary Fixation Humeral Guide Wire - Smooth, ZMS Intramedullary Fixation Smooth Guide Wire, Zimmer Natural Nail System - Tear Drop Guide Wire, and Pressure Sentinel Intramedullary Reaming System, Guide Wire (2018-10-30)November 28, 2018 · Medical devices · Medical devices · Type II
- Access hsTnI Reagent (2018-10-15)November 28, 2018 · Medical devices · Medical devices · Type III
- Giraffe OmniBed (2018-10-11)November 28, 2018 · Medical devices · Medical devices · Type II
- Chemstrip 5, Chemstrip 7 and Urisys 1100 (2018-08-27)November 28, 2018 · Medical devices · Medical devices · Type II
- NexGen Complete Knee Solution and Rotating Hinge Knee (2018-11-04)November 28, 2018 · Medical devices · Medical devices · Type III
- 8mm Monopolar Curved Scissors (2018-10-23)November 28, 2018 · Medical devices · Medical devices · Type III
- Insulia (2018-10-11)November 28, 2018 · Medical devices · Medical devices · Type II
- Nova and TXR Nova Radiographic System (2018-08-22)November 28, 2018 · Medical devices · Medical devices · Type II
- Captus 3000 and 700 (2018-11-04)November 28, 2018 · Medical devices · Medical devices · Type II
- Arrow EZ-IO 45mm Needle Set + Stabilizer Kit (2018-10-31)November 28, 2018 · Medical devices · Medical devices · Type III
- Implant Thread Cleaning Tap NOBRPL (2018-10-13)November 28, 2018 · Medical devices · Medical devices · Type III
- Reticulum II Staining Kit (2018-10-22)November 28, 2018 · Medical devices · Medical devices · Type III
- Mueller-Hinton Broth with 3% lysed horse blood (2018-03-18)November 28, 2018 · Medical devices · Medical devices · Type II
- PNEUMOCLEAR Heated High-Flow Tube Set (2018-10-21)November 28, 2018 · Medical devices · Medical devices · Type III
- Hex Driver, 2.5/110mm AO (2018-01-13)November 28, 2018 · Medical devices · Medical devices · Type III
- VITROS ECi Immunodiagnostic Products (2018-11-01)November 28, 2018 · Medical devices · Medical devices · Type II
- Coaguchek XS Strips (2018-10-10)November 28, 2018 · Medical devices · Medical devices · Type III
- LifeStream Balloon Expandable Vascular Covered Stent (2018-10-29)November 15, 2018 · Medical devices · Medical devices · Type II
- Stockert Heater Cooler System 3T (2018-10-28)November 15, 2018 · Medical devices · Medical devices · Type II
- NobelSpeedy Shorty Implant and RP (2018-10-29)November 15, 2018 · Medical devices · Medical devices · Type II
- ExactaMix EVA Container (2018-09-30)November 15, 2018 · Biologic or vaccine - Medical devices · Medical devices · Type I
- Human IgM kit for use on SPAPLUS (2018-10-23)November 15, 2018 · Medical devices · Medical devices · Type II
- Kodak DirectView DR 7500 System (2018-10-28)November 15, 2018 · Medical devices · Medical devices · Type II
- Symbia Evo Excel (2018-10-09)November 15, 2018 · Medical devices · Medical devices · Type III
- Evidence System - Analyser (2018-10-11)November 15, 2018 · Medical devices · Medical devices · Type III
- CDI Blood Parameter Monitoring System 500 H/Sat Probe Assembly (2018-10-10)November 15, 2018 · Medical devices · Medical devices · Type III
- Warmy Magic Bag (2018-10-21)November 15, 2018 · Medical devices · Medical devices · Type III
- VITROS 5, 1 FS Chemistry System, VITROS 3600 Immunodiagnostic System, VITROS 5600 Integrated System, and VITROS 4600 Chemistry System (2018-10-21)November 15, 2018 · Medical devices · Medical devices · Type II
- O-arm O2 Imaging System (2018-10-14)November 15, 2018 · Medical devices · Medical devices · Type III
- RHD BeadChip (2018-10-14)November 15, 2018 · Medical devices · Medical devices · Type III
- WaterLock 2 and WaterLock 2 Infinity ID (2018-10-11)November 15, 2018 · Medical devices · Medical devices · Type II
- Revolution CT (2018-10-17)November 15, 2018 · Medical devices · Medical devices · Type III
- VITEK 2 System Susceptibility and VITEK 2 Compact 30 and 60 System - Susceptibility Test Cards (2018-10-15)November 15, 2018 · Medical devices · Medical devices · Type II
- Eurotrol Hemoglobin Controls (2018-10-17)November 2, 2018 · Medical devices · Medical devices · Type II
- Artis zee biplane, Artis Q and Artis Q.zen (2018-10-24)November 2, 2018 · Medical devices · Medical devices · Type II
- Cardiosave Hybrid IABP (2018-09-26)November 2, 2018 · Medical devices · Medical devices · Type II
- Alinity i Free T3 Reagent Kit and Alinity I Total T3 Reagent Kit (2018-10-16)November 2, 2018 · Medical devices · Medical devices · Type III
- StealthStation S7 Cranial Software (2018-10-03)November 2, 2018 · Medical devices · Medical devices · Type II
- CareLink 2090 Programmer and CareLink Encore 29901 Programmer (2018-10-08)November 2, 2018 · Medical devices · Medical devices · Type II
- iChem VELOCITY Urine Chemistry strips (2018-10-10)November 2, 2018 · Medical devices · Medical devices · Type II
- Dimension Vista System-Lactate Dehydrogenase Flex (LDI) Assay (2018-10-17)November 2, 2018 · Medical devices · Medical devices · Type III
- FilmArray Meningitis/Encephalitis (ME) Panel (2018-09-20)November 2, 2018 · Medical devices · Medical devices · Type II
- Puritan Bennett 980 Series Ventilator -Ventilator (2018-09-20)November 2, 2018 · Medical devices · Medical devices · Type II
- Centricity Universal Viewer (2018-10-11)November 2, 2018 · Medical devices · Medical devices · Type II
- LIAISON XL Starter Kit (2018-10-23)November 2, 2018 · Medical devices · Medical devices · Type III
- Dimension Vista 1500 and 500 Analyzer (2018-10-18)November 2, 2018 · Medical devices · Medical devices · Type III
- PLEX Elite 9000 (2018-10-22)November 2, 2018 · Medical devices · Medical devices · Type II
- HeartStart FR3. Defibrillator (2018-10-02)November 2, 2018 · Medical devices · Medical devices · Type II
- VITROS Chemistry Products 5,1 FS Chemistry System - dLDL Assay (2018-10-08)November 2, 2018 · Medical devices · Medical devices · Type III
- Neurosign V4 Intraoperative Nerve Monitor (2018-10-21)November 2, 2018 · Medical devices · Medical devices · Type II
- ARCHITECT Total and Free T3 Reagent Kit (2018-10-16)November 2, 2018 · Medical devices · Medical devices · Type II
- IMPRA ePTFE Vascular Graft, IMPRA CARBOFLO ePTFE Vascular Graft, and DISTAFLO Bypass Graft (2018-10-05)November 2, 2018 · Medical devices · Medical devices · Type II
- Compress Device Centering Sleeve, Anti-Rotation Spindle, Anti-Rotation Elliptical Spindle, and Compress Instrument Drill for Anti-Rotation Pin (2018-10-22)November 2, 2018 · Medical devices · Medical devices · Type III
- BD MAX System (2018-10-03)October 26, 2018 · Medical devices · Medical devices · Type III
- IMPAK Elastic Acrylic Resin Liquid (2018-09-16)October 26, 2018 · Medical devices · Medical devices · Type III
- Medfusion Model 4000 (2018-10-07)October 26, 2018 · Medical devices · Medical devices · Type II
- nordicBrainEx (2018-07-05)October 26, 2018 · Medical devices · Medical devices · Type II
- Synapse Cardiovascular Image and Information & Viewing Management (2018-05-08)October 26, 2018 · Medical devices · Medical devices · Type II
- ARCHITECT HAVAb-IgG and HAVAb-IgM Reagent Kit, and Alinity i HAVAb IgG Reagent Kit (2018-09-27)October 26, 2018 · Medical devices · Medical devices · Type II
- BrightMatter Guide (2018-10-08)October 26, 2018 · Medical devices · Medical devices · Type II
- Liquid Cardiac Controls Troponin T (2018-10-04)October 26, 2018 · Medical devices · Medical devices · Type II
- Quadrox-i Neonatal Oxygenator, Quadrox-i Neonatal Oxygenator with Integrated Hardshell Reservoir, and Custom Pack With Softline (2018-10-16)October 26, 2018 · Medical devices · Medical devices · Type II
- Nara Hospital Bassinet (2018-10-15)October 26, 2018 · Medical devices · Medical devices · Type I
- Temporary Bipolar Pacing Leads (2018-09-09)October 26, 2018 · Medical devices · Medical devices · Type II
- Hemoglobin A1c Controls Level 1 and 2 (2018-10-10)October 26, 2018 · Medical devices · Medical devices · Type III
- Artis zee multi-purpose and Artis Q (2018-10-14)October 26, 2018 · Medical devices · Medical devices · Type III
- Biograph mMR System (2018-10-14)October 26, 2018 · Medical devices · Medical devices · Type III
- Carescape R860 (2018-10-04)October 26, 2018 · Medical devices · Medical devices · Type II
- Spirit Bed (2018-10-08)October 26, 2018 · Medical devices · Medical devices · Type II
- SugarPlum Glucose Lancet 1.8 MM and 1.0MM - 21G, BOX OF 100 (2018-10-14)October 26, 2018 · Medical devices · Medical devices · Type III
- Adult IV Set with Rate Flow Regulator, Rate Flow Regulator Extension Set, and Rate Flow Regulator IV Set (2018-10-01)October 26, 2018 · Medical devices · Medical devices · Type II
- Dimension EXL Analyzer with LM, Dimension EXL 200 Analyzer, and Dimension RxL Max w/HM Analyzer (2018-10-04)October 26, 2018 · Medical devices · Medical devices · Type III
- Monnal T60 (2018-07-09)October 26, 2018 · Medical devices · Medical devices · Type II
- Fluence Cartridge (2018-10-01)October 26, 2018 · Medical devices · Medical devices · Type III
- BD PCEA Administration Set (2018-10-01)October 19, 2018 · Medical devices · Medical devices · Type II
- Atellica CH 930, IM 1300, and IM 1600 Analyzer (2018-09-30)October 19, 2018 · Medical devices · Medical devices · Type II
- Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer (2018-06-12)October 19, 2018 · Medical devices · Medical devices · Type III
- Argus II Retinal Prosthesis Kit (2018-09-04)October 19, 2018 · Medical devices · Medical devices · Type III
- Zilver 518 and 635 Biliary Stent (2018-09-26)October 19, 2018 · Medical devices · Medical devices · Type II
- BD FocalPoint GS Review Station, Slide Profiler, and FocalPoint Slide Profiler (Refurbished) (2018-09-20)October 19, 2018 · Medical devices · Medical devices · Type III
- HydroMARK Breast Biopsy Marker (2018-09-25)October 19, 2018 · Medical devices · Medical devices · Type III
- ARTIS pheno (2018-09-20)October 19, 2018 · Medical devices · Medical devices · Type II
- StartVPS Clear Bite (4-pack) (impression material) (2018-09-23)October 19, 2018 · Medical devices · Medical devices · Type III
- StageOne Hip Cement Spacer Mold with Reinforcement 9 x 125 mm 51 mm (2018-09-27)October 19, 2018 · Medical devices · Medical devices · Type III
- Tremoflo C-100 Airwave Oscillometry System (2018-09-10)October 19, 2018 · Medical devices · Medical devices · Type III
- Various B.Braun Medical Inc's Catheter Connector, Nerve Block Sets, Epidural Catheter Sets, Epidural Catheter Tray and Epidural Sets (2018-08-14)October 19, 2018 · Medical devices · Medical devices · Type II
- Kerlix 100% Bandage Cotton Large, Kerlix AMD Antimicrobial Large Roll, DERMACEA Fluff Roll, and Kerlix Gauze Large Roll (2018-08-07)October 19, 2018 · Medical devices · Medical devices · Type II
- Parietex Composite Parastomal Mesh (2018-10-08)October 19, 2018 · Medical devices · Medical devices · Type I
- Eltrac 471 II (2016-12-19)October 19, 2018 · Medical devices · Medical devices · Type II
- Artis zee Ceiling System (2018-10-03)October 19, 2018 · Medical devices · Medical devices · Type III
- Pruitt F3-S Polyurethane Outlying Carotid Shunt (2018-10-01)October 19, 2018 · Medical devices · Medical devices · Type II
- RayStation (2018-09-18)October 19, 2018 · Medical devices · Medical devices · Type II
- Honeywell Laser Aid Disposable Eyepatch (2018-08-26)October 19, 2018 · Medical devices · Medical devices · Type II
- Stimuplex Ultra 360 Insulated Echogenic Needle and Ultraplex 360 Non-Stimulating Echogenic Needle (2018-09-24)October 19, 2018 · Medical devices · Medical devices · Type II
- Overhead Lift Roomer S and Altair (2016-07-07)October 19, 2018 · Medical devices · Medical devices · Type III
- Cobas e411 Immunoassay Analyzer (2018-09-24)October 19, 2018 · Medical devices · Medical devices · Type II
- Dimension Sample Probe Cleaner (2018-09-27)October 19, 2018 · Medical devices · Medical devices · Type III
- buddy Disposable Set (2018-09-18)October 19, 2018 · Medical devices · Medical devices · Type III
- Access System - Cortisol Assay, UniCel DxI 600 and 800 Access Immunoassay System - Cortisol Assay (2018-09-16)October 19, 2018 · Medical devices · Medical devices · Type II
- ProFile Vortex Blue (2018-09-24)October 19, 2018 · Medical devices · Medical devices · Type III
- TEXAS Bronchoscope Tube and Powerdrive ART1 - Tracheoscope Tube (2018-09-17)October 19, 2018 · Medical devices · Medical devices · Type II
- C-Section Pack (2018-08-06)October 19, 2018 · Medical devices · Medical devices · Type III
- Health Canada reminds Canadians of the risks of decorative contact lensesOctober 12, 2018 · Medical devices · Product safety
- AirLife Arterial Blood Gas (ABG) Sampling Aspirators, Micro and Quick AGB Samplers (2018-04-09)October 5, 2018 · Medical devices · Medical devices · Type III
- Zenith Alpha Abdominal Endovascular Graft (2018-09-17)October 5, 2018 · Medical devices · Medical devices · Type II
- Millennium MG System and Millennium MyoSIGHT Cardiology Imaging System (2018-09-17)October 5, 2018 · Medical devices · Medical devices · Type II
- Solar 8000M/I System - Patient Monitor, Solar 9500 Information Monitor, and Dash 3000/4000/5000 Patient Monitor (2018-09-20)October 5, 2018 · Medical devices · Medical devices · Type II
- BonD-MaX and BOND-III System (2018-09-13)October 5, 2018 · Medical devices · Medical devices · Type II
- CentriMag Motor (2018-09-05)October 5, 2018 · Medical devices · Medical devices · Type I
- Neuro Omega system (2018-09-04)October 5, 2018 · Medical devices · Medical devices · Type II
- ONLINE DAT Amphetamines II for Roche Hitachi 917 and Modular P Analyzers, ONLINE DAT Amphetamines II For Cobas Integra and Amphetamines II (AMPS2) (2018-08-31)October 5, 2018 · Medical devices · Medical devices · Type III
- Dimension Vista Lipase (LIPL), Dimension Clinical Chemistry, EXL and Xpand System - Lipase Flex (LIPL) Assay (2018-09-13)October 5, 2018 · Medical devices · Medical devices · Type III
- FilmArray Blood Culture Identification Panel (BCID) Panel (2018-09-06)October 5, 2018 · Medical devices · Medical devices · Type II
- Digital Diagnost (2018-09-25)October 5, 2018 · Medical devices · Medical devices · Type II
- Alinity i Processing Module (2018-09-18)October 5, 2018 · Medical devices · Medical devices · Type II
- SYNCHRON Systems Lipase (LIP) Reagent (2018-09-11)October 5, 2018 · Medical devices · Medical devices · Type III
- HydroSet Injectable HA Cement (2018-09-17)September 28, 2018 · Medical devices · Medical devices · Type II
- CooperSurgical Single-Use Elastic Stays (2018-09-04)September 28, 2018 · Medical devices · Medical devices · Type II
- Sokinox No Delivering And Monitoring System (2018-09-14)September 28, 2018 · Medical devices · Medical devices · Type II
- TiLite Manual Wheelchair (2018-09-06)September 28, 2018 · Medical devices · Medical devices · Type II
- Activa PC+S Implantable Neurostimulator (INS) (2018-08-29)September 28, 2018 · Medical devices · Medical devices · Type III
- Altrix Precision Temperature Management System (2018-09-04)September 28, 2018 · Medical devices · Medical devices · Type III
- Entroy Pool Lift (2018-03-16)September 28, 2018 · Medical devices · Medical devices · Type II
- Tosoh AIA 360 Analyzer (2018-08-29)September 28, 2018 · Medical devices · Medical devices · Type III
- Single-Use Colpo-Pneumo Occluder (2018-09-04)September 28, 2018 · Medical devices · Medical devices · Type II
- IVES Disposable Conductive Plastic EEG Electrode CPE-23/D (2018-09-10)September 28, 2018 · Medical devices · Medical devices · Type II
- Female Luer Lock (2018-09-07)September 28, 2018 · Medical devices · Medical devices · Type I
- HeartWare Ventricular Assist System - HeartWare Controller (2018-08-29)September 28, 2018 · Medical devices · Medical devices · Type II
- Instrument Arm Drape, Disposable Accessory Kit, 3-Arm and 4-Arm (2018-08-31)September 28, 2018 · Medical devices · Medical devices · Type II
- O-Arm 1000 Imaging System (2018-09-06)September 28, 2018 · Medical devices · Medical devices · Type III
- RADREX-i (2018-09-12)September 28, 2018 · Medical devices · Medical devices · Type II
- Giraffe, Panda Freestanding, and Panda iRes Warmer (2018-09-10)September 28, 2018 · Medical devices · Medical devices · Type III
- syngo Dynamics (2018-08-27)September 17, 2018 · Medical devices · Medical devices · Type III
- Unipolar Adapter 5 mm, Unipolar Adapter 6mm, Bi Polar Adapter, Cap and Sleeve Kit, and BiPolar Lead, 25CM, BiPolar lead 54CM (2018-08-31)September 17, 2018 · Medical devices · Medical devices · Type III
- Occlutech Sizing Balloon (2018-08-31)September 17, 2018 · Medical devices · Medical devices · Type III
- Leica M525 F20 Microscope Systems (2018-08-17)September 17, 2018 · Medical devices · Medical devices · Type II
- DSX- Revelation software 6.08-6.28 (2018-08-03)September 17, 2018 · Medical devices · Medical devices · Type III
- Lipase OSR6x30, Uric Acid OSR6x98, and Enzymatic Creatinine OSR6x204 (2018-08-27)September 17, 2018 · Medical devices · Medical devices · Type II
- VITROS ECI Immunodiagnostic Products Vitamin B12 Reagent Pack Controls & CA (2018-08-31)September 17, 2018 · Medical devices · Medical devices · Type III
- Various Roche Detection, Amplification Kits and Primary Antibody (2018-08-16)September 17, 2018 · Medical devices · Medical devices · Type II
- Mitek Screw and Washer Depth Gauge (2018-08-30)September 17, 2018 · Medical devices · Medical devices · Type III
- TrueBeam, TrueBeam STx, and TrueBeam Edge (2018-08-22)September 7, 2018 · Medical devices · Medical devices · Type II
- Siemans Dimension Software Version 10.2.2 (2018-06-07)September 7, 2018 · Medical devices · Medical devices · Type III
- EVIS EXERA and EVIS 140 Video System - Duodenovideoscope (2018-08-14)September 7, 2018 · Medical devices · Medical devices · Type II
- ViaValve Safety I.V. Catheter (2018-08-16)September 7, 2018 · Medical devices · Medical devices · Type II
- Polyflux Revaclear Max Dialyzer (2017-12-15)September 7, 2018 · Medical devices · Medical devices · Type III
- Sickledex (2018-08-17)September 7, 2018 · Medical devices · Medical devices · Type II
- CyPass Micro-Stent Model 241 (2018-08-30)September 7, 2018 · Medical devices · Medical devices · Type I
- Ambu Aura40 Standard Reusable Laryngeal Mask (2018-08-08)September 7, 2018 · Biologic or vaccine - Medical devices · Medical devices · Type II
- Ovation, Ovation Prime, and Ovation IX Abdominal Stent Graft System (2018-08-30)September 7, 2018 · Medical devices · Medical devices · Type II
- Remel Selective Rapid Urea (2018-08-21)September 7, 2018 · Medical devices · Medical devices · Type III
- Med-Rx Epidural Anesthesia Kit (2018-08-09)September 7, 2018 · Medical devices · Medical devices · Type II
- Cellex Photopheresis System (2018-08-10)September 7, 2018 · Medical devices · Medical devices · Type II
- Hexapod Strut (2018-08-17)September 7, 2018 · Medical devices · Medical devices · Type II
- Paradigm Insulin Infusion Pumps Remote Programmer (2018-08-13)September 7, 2018 · Medical devices · Medical devices · Type III
- Oxylog 3000 (2018-07-24)September 7, 2018 · Medical devices · Medical devices · Type II
- Optical Surface Monitoring System (OSMS) (2018-08-10)August 31, 2018 · Medical devices · Medical devices · Type III
- Citadel Plus (2018-08-10)August 31, 2018 · Medical devices · Medical devices · Type III
- uTASWako DCP and uTASWako AFP-L3 (2018-07-27)August 31, 2018 · Medical devices · Medical devices · Type III
- Heartstart Defibrillation Pads (2018-08-10)August 31, 2018 · Medical devices · Medical devices · Type II
- Parapost Plus Ti5 (2018-08-09)August 31, 2018 · Medical devices · Medical devices · Type III
- DMEM (2018-06-14)August 31, 2018 · Medical devices · Medical devices · Type II
- Philips SureSigns VM4, VM6, VM8, VS3, VSV (Vital Signs Viewer) Central Station, VS2 Vital Signs Monitor, and VS4 Vital Signs Monitor System - Vital Signs Monitor (2018-07-04)August 31, 2018 · Medical devices · Medical devices · Type II
- DX-D 600 (2018-08-15)August 31, 2018 · Medical devices · Medical devices · Type II
- VITROS 5600 Integrated System (2018-08-20)August 31, 2018 · Medical devices · Medical devices · Type II
- Multi-Drug Screen Test ECO II Cup (2018-08-16)August 31, 2018 · Medical devices · Medical devices · Type III
- TempSure Vitalia (2018-08-13)August 31, 2018 · Medical devices · Medical devices · Type II
- Thio med w/ dex, hem, vit k (10mL) (2018-08-13)August 31, 2018 · Medical devices · Medical devices · Type II
- HEMA-TEK Slide Stainer - Stain Pak - Modified Wright's Stain and Wright-Giemsa Stain (2018-08-13)August 31, 2018 · Medical devices · Medical devices · Type III
- Mammotome Revolve Stereotactic Prob and Mammotome Revolve Ultrasound Probes (2018-06-27)August 31, 2018 · Medical devices · Medical devices · Type III
- ProTaper GOLD F1 21mm (2018-08-07)August 31, 2018 · Medical devices · Medical devices · Type III
- Thermablate Disposable Cartridge and Thermablate Treatment Control Unit Kit (2018-07-18)August 31, 2018 · Medical devices · Medical devices · Type III
- FlashBuster (2018-08-27)August 27, 2018 · Medical devices · Medical devices · Type III
- CAPNOSTREAM 20 AND CAPNOSTREAM 20P (2018-07-31)August 24, 2018 · Medical devices · Medical devices · Type II
- Ysio Radiography X-Ray System - Full Motorized (2018-08-08)August 24, 2018 · Medical devices · Medical devices · Type II
- Alinity Ci-Series System Control Module (2018-08-07)August 24, 2018 · Medical devices · Medical devices · Type III
- LIAISON Control Measles IgM (2018-08-10)August 24, 2018 · Medical devices · Medical devices · Type III
- Ysio Max (2018-08-08)August 24, 2018 · Medical devices · Medical devices · Type II
- Multix Fusion Digital (2018-08-08)August 24, 2018 · Medical devices · Medical devices · Type II
- sterEOS Workstation System and EOS 2D/3D Workstation (2018-08-01)August 24, 2018 · Medical devices · Medical devices · Type II
- EZ Single Cytofunnel Brown (2018-07-12)August 24, 2018 · Medical devices · Medical devices · Type III
- Tissue-Tek AutoSection Automated Microtome (2018-07-11)August 24, 2018 · Medical devices · Medical devices · Type II
- Tapered Ridge Expanders, 4.6mm (2018-04-26)August 24, 2018 · Medical devices · Medical devices · Type III
- DUREX Real Feel Extra Lubricated 10ct condoms (2018-07-30)August 17, 2018 · Medical devices · Medical devices · Type II
- Sonic Fusion Flossing Toothbrush (2018-07-02)August 17, 2018 · Medical devices · Medical devices · Type II
- Enterprise Imaging for Radiology (2018-08-03)August 17, 2018 · Medical devices · Medical devices · Type III
- AIRO Mobile CT Scanner (2018-08-07)August 17, 2018 · Medical devices · Medical devices · Type I
- Heater-Cooler Unit HCU 40 (2018-08-03)August 17, 2018 · Medical devices · Medical devices · Type II
- Bipolar Electrode Catheters (2018-07-31)August 17, 2018 · Medical devices · Medical devices · Type II
- Permobil Powered Wheelchairs (2018-08-06)August 17, 2018 · Medical devices · Medical devices · Type II
- ARCHITECT c8000, c16000, c4000 Processing Module (2018-07-20)August 17, 2018 · Medical devices · Medical devices · Type II
- STAINBUSTER Bur (2018-07-30)August 17, 2018 · Medical devices · Medical devices · Type III
- ARKON Anesthesia Delivery System (2018-07-16)August 17, 2018 · Medical devices · Medical devices · Type II
- Agglu. Sera Shigella boydii polyvalent 2 (7 to 11) (2018-07-03)August 17, 2018 · Medical devices · Medical devices · Type III
- Digital Diagnost (2018-06-12)August 17, 2018 · Medical devices · Medical devices · Type II
- Allura Xper FD10, FD20, FD10/10, and FD20/10 (2018-06-12)August 17, 2018 · Medical devices · Medical devices · Type II
- ADVIA Centaur and ADVIA Centaur CP System - Creatine Kinase-MB (CKMB) Assay (2018-07-27)August 17, 2018 · Medical devices · Medical devices · Type III
- VITROS Eci Immunidiagnostic Products TSH Reagent Pack, Prolactin Reagent Pack, FSH Reagent Pack, Folate Reagent Pack 1/2, and PSA Reagent Pack (2018-07-13)August 17, 2018 · Medical devices · Medical devices · Type II
- BIS Complete Monitoring System (2018-07-26)August 17, 2018 · Medical devices · Medical devices · Type II
- Various B. Braun Medical's Catheter, Nerve Block, and Epidural Sets (2018-07-24)August 17, 2018 · Medical devices · Medical devices · Type II
- Dimension Vista LOCI Reaction Vessels (2018-07-17)August 17, 2018 · Medical devices · Medical devices · Type III
- X-CAL, Sysmex E-Check, 8Check 3WP X-TRA Control, Sysmex SCS-1000 Universal Calibrator, XN CHECK, XN CAL, XN CAL PF, XN CAL - CUSTOMER SET, XN CAL PF - CUSTOMER SET, and XN-L CHECK (2018-05-08)August 17, 2018 · Medical devices · Medical devices · Type III
- SHOEBOX Audiometry Pro (2018-07-20)August 17, 2018 · Medical devices · Medical devices · Type III
- Formula Resector Cutter, Formula Aggressive Plus Cutter and Formula Barrel Bur (2018-08-08)August 17, 2018 · Medical devices · Medical devices · Type II
- IH-COM Kit (2018-08-09)August 17, 2018 · Medical devices · Medical devices · Type II
- MESORB (2018-06-15)August 17, 2018 · Medical devices · Medical devices · Type III
- MOSAIQ (2018-08-03)August 17, 2018 · Medical devices · Medical devices · Type II
- PRO-NOX Nitrous Oxide Delivery System (2018-05-09)August 17, 2018 · Medical devices · Medical devices · Type II
- Cobas 6500 U601 Urinalys system-Urine Analyzer and Cobas U701 Microscopy Analyzer (2018-07-19)August 17, 2018 · Medical devices · Medical devices · Type III
- Fluorocell PLT (2018-07-27)August 17, 2018 · Medical devices · Medical devices · Type II
- Legacy 3 Implant SBM 5.2mmDx16mmL, 4.5mmD platform (2018-08-10)August 17, 2018 · Medical devices · Medical devices · Type II
- RAPIDPoint 405, 500 and RAPIDLab 1245 Blood Gas Analyzer (2018-07-24)August 17, 2018 · Medical devices · Medical devices · Type II
- SOMATOM Force (2018-08-02)August 17, 2018 · Medical devices · Medical devices · Type III
- T2 Proximal Humeral Nail System - Long Nail (2018-06-15)August 17, 2018 · Medical devices · Medical devices · Type II
- STA System - Analyzers (Class 2), STA and STA-R Evolution System - Coagulation System - Prothrombin Time, STA Satellite - Neoplastine CL and Neoplastine CL (Thromboplastin) (2018-07-18)August 17, 2018 · Medical devices · Medical devices · Type II
- Artis Q and Artis Q.Zen (2018-07-30)August 17, 2018 · Medical devices · Medical devices · Type II
- da Vinci S/Si and da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors (2018-08-06)August 17, 2018 · Medical devices · Medical devices · Type III
- Panocell-10 (2018-07-27)August 17, 2018 · Medical devices · Medical devices · Type III
- Carestation 650 (2018-07-24)August 17, 2018 · Medical devices · Medical devices · Type II
- ARCHITECT I Sytem - EBV VCA IgM Reagent Kit (2018-07-26)August 2, 2018 · Medical devices · Medical devices · Type I
- EZ1 Advanced XL (2018-07-25)August 2, 2018 · Medical devices · Medical devices · Type II
- ARCHITECT System - Creatine Kinase Assay (2018-07-20)August 2, 2018 · Medical devices · Medical devices · Type II
- PENTAX Video Duodenoscope (2018-07-20)August 2, 2018 · Medical devices · Medical devices · Type II
- IS3000, Redundant Medical Grade Power Supply, Reduced Fan Speed (2018-07-16)August 2, 2018 · Biologic or vaccine - Medical devices · Medical devices · Type II
- 1-Day Acuvue Moist (2018-07-26)August 2, 2018 · Medical devices · Medical devices · Type III
- Allura Xper FD10/10 - Main Unit, Allura Xper FD10, Allura Xper FD20 - Main Unit and Allura Xper FD20/10 System - Main Unit (2018-07-17)August 2, 2018 · Medical devices · Medical devices · Type II
- Human IgM kit for use on SPAPLUS (2018-07-25)August 2, 2018 · Medical devices · Medical devices · Type II
- ErgoJust Mobile Carts (2018-05-14)August 2, 2018 · Medical devices · Medical devices · Type II
- Alcon or Endure LuxOR E71 Ophthalmic Microscope and Q-Vue Ophthalmic Microscope (2018-07-18)August 2, 2018 · Medical devices · Medical devices · Type II
- CVM Material for Calibration Verification of Blood Gas, Electrolyte, Total Hemoglobin, Bilirubin, and Metabolite Systems (2018-07-16)August 2, 2018 · Medical devices · Medical devices · Type III
- ComboLab System - Main Unit, CardioLab System - Main Unit, Mac-Lab System - Main Unit, and Mac-Lab Systems - Integrated Electronics Box (2018-06-14)July 27, 2018 · Medical devices · Medical devices · Type II
- ACUTRONIC fabian HFO ventilator (2014-11-27)July 27, 2018 · Medical devices · Medical devices · Type II
- Duo Flow Double Lumen and Soft-Line Catheter Sets, Raulerson Pre-Curved Duo-Flow IJ Catgeter With Soft Tip (2018-07-13)July 27, 2018 · Medical devices · Medical devices · Type II
- Stat Profile Prime CCS Comp Analyzer (2017-06-09)July 27, 2018 · Medical devices · Medical devices · Type II
- Reliance 1227 Cart and Utensil Washer/Disinfector (2018-05-21)July 27, 2018 · Medical devices · Medical devices · Type III
- Elecsys Anti-TPO (2018-07-11)July 27, 2018 · Medical devices · Medical devices · Type III
- Nanodyne NEO Intravenous Filter Set (2018-06-28)July 27, 2018 · Medical devices · Medical devices · Type III
- IMMULITE and IMMULITE 1000 System- Prostate-Specific Antigen (PSA) Assay (2018-07-19)July 27, 2018 · Medical devices · Medical devices · Type III
- AMSCO V-PRO 1, AMSCO V-PRO 1 Plus, and AMSCO V-PRO maX Low Temperature Sterilization System (2018-07-23)July 27, 2018 · Medical devices · Medical devices · Type II
- VITROS Chemistry Products CREA Slides, CL - Slides (Chloride), and C1 - Slides (2018-07-12)July 27, 2018 · Medical devices · Medical devices · Type III
- INTERTAN 11.5mm x 18cm 125D (2018-06-15)July 27, 2018 · Medical devices · Medical devices · Type II
- Alinity ci-series System Control Module (SCM) (2018-07-13)July 27, 2018 · Medical devices · Medical devices · Type III
- Cobas p 612 pre-analytical system LCP1 (2018-07-12)July 27, 2018 · Medical devices · Medical devices · Type III
- Cobas 6500 Cobas u 601 and u 701 (2018-06-20)July 27, 2018 · Medical devices · Medical devices · Type III
- HistoCore SPECTRA ST Stainer (2018-05-29)July 27, 2018 · Medical devices · Medical devices · Type II
- ThromboType (2018-07-05)July 19, 2018 · Medical devices · Medical devices · Type III
- Platinium SonR CRT-D (2018-07-09)July 19, 2018 · Medical devices · Medical devices · Type II
- RayStation and RayPlan (2018-06-29)July 19, 2018 · Medical devices · Medical devices · Type II
- Optima CT540 Series CT Scanner System (2018-04-27)July 19, 2018 · Medical devices · Medical devices · Type II
- Optima CT660 and Revolution EVO (2018-04-27)July 19, 2018 · Medical devices · Medical devices · Type II
- MAYFIELD Infinity XR2 Base Unit, Low Profile Base Unit, Base Unit-Extended and MAYFIELD Spine Table Adaptor Radiolucent (2018-06-29)July 19, 2018 · Medical devices · Medical devices · Type II
- Chorionic Villus Sampling Needle Set (2018-07-03)July 19, 2018 · Medical devices · Medical devices · Type III
- Lysercell WDF (2018-06-25)July 19, 2018 · Medical devices · Medical devices · Type III
- Artis Zeego Multi-Axis, Artis Zee Multi-Purpose, Artis Zee Floor, and Artis Zee Ceiling (2018-06-28)July 19, 2018 · Medical devices · Medical devices · Type III
- Pro-Vent Plus, Anaerobic Pulsator Plus, Pulsator Liquid Heparin, and Dry Pulsator Plus Arterial Blood Gas Sampling Kit (2018-06-26)July 19, 2018 · Medical devices · Medical devices · Type III
- Discovery MR750w 3.0T Magnetic Resonance Imaging System (2018-06-06)July 19, 2018 · Medical devices · Medical devices · Type II
- CARESCAPE Monitor B650 (2018-05-31)July 19, 2018 · Medical devices · Medical devices · Type II
- Elecsys Anti-HAV (2018-06-19)July 19, 2018 · Medical devices · Medical devices · Type III
- Barrel Clamp Guide (2018-04-04)July 19, 2018 · Medical devices · Medical devices · Type II
- Turnpike LP Catheter (2018-06-28)July 13, 2018 · Medical devices · Medical devices · Type III
- LAPRAOSCOPIE and ENDOCHOLECYSTECTOMIE Presource Kits Containing Hydroline and Pulse Wave Trumpet Valves (2018-07-04)July 13, 2018 · Medical devices · Medical devices · Type II
- ARIES and ARIES M1 System (2018-07-02)July 13, 2018 · Medical devices · Medical devices · Type II
- Vmax Encore 28.6 (2018-06-26)July 13, 2018 · Medical devices · Medical devices · Type III
- 5008 Cordiax HD-PAED option (2018-06-26)July 13, 2018 · Medical devices · Medical devices · Type I
- Gentec Medical Air Regulators - 287 MA Series (2018-06-27)July 13, 2018 · Medical devices · Medical devices · Type II
- AEQUALIS Humeral Nail Drill Bit (2018-05-11)July 13, 2018 · Medical devices · Medical devices · Type II
- MAESTRO 4000 Cardiac Ablation System (2018-06-20)July 13, 2018 · Medical devices · Medical devices · Type II
- ARTIS Q, ARTIS Q. ZEN, and ARTIS PHENO (2018-06-22)July 13, 2018 · Medical devices · Medical devices · Type II
- MED-RX Feeding Tube (2018-06-02)July 13, 2018 · Medical devices · Medical devices · Type II
- Systeme d'imagerie CryoVizion (2018-07-06)July 6, 2018 · Medical devices · Medical devices · Type II
- HCG STAT elecsys cobas e 100 V2, Troponin I Elecsys cobas e 100, Troponin T hs STAT Elecsys, cobas e 100, Myoglobin STAT Elecsys cbas e 100 (2018-06-05)July 6, 2018 · Medical devices · Medical devices · Type III
- Asena GH and Alaris Syringe Pumps (2018-06-25)July 5, 2018 · Medical devices · Medical devices · Type II
- JOURNEY Knee System - Femoral OXINIUM and COCR Nonporous Bi-Cruciate Stabilized (BCS) (2018-06-19)July 5, 2018 · Medical devices · Medical devices · Type II
- Medtronic's EnTrust Dual Chamber (2018-06-21)July 5, 2018 · Medical devices · Medical devices · Type I
- Blom-Singer Classic Indwelling Voice Prosthesis - Sterile Series (2018-06-22)July 5, 2018 · Medical devices · Medical devices · Type III
- Abviser Intra-Abdominal Pressure Monitoring Kit (2018-06-21)July 5, 2018 · Medical devices · Medical devices · Type II
- ABL800 Analyzers (2018-06-19)July 5, 2018 · Medical devices · Medical devices · Type II
- ABL800 Flex Analyzer (2018-06-25)July 5, 2018 · Medical devices · Medical devices · Type II
- Acumed Cortical Screws (2018-06-07)July 5, 2018 · Medical devices · Medical devices · Type III
- Invia Motion Negative Pressure Wound Therapy (NPWT) System (2018-06-05)July 5, 2018 · Medical devices · Medical devices · Type III
- Platelet Aggregation Kit (2018-06-01)July 5, 2018 · Medical devices · Medical devices · Type III
- Discovery NM/CT 670 ES (2018-05-30)July 5, 2018 · Medical devices · Medical devices · Type II
- OX1 Oxacillin (2018-06-22)July 5, 2018 · Medical devices · Medical devices · Type III
- Fargo Guiding Catheter (2018-06-28)July 5, 2018 · Medical devices · Medical devices · Type III
- Legacy Implant Closed-Tray Transfer 3.5mmD Platform (2018-05-18)July 5, 2018 · Medical devices · Medical devices · Type II
- Adult flexible tracheostomy Tube Cuffless 6.5 mm I.D. (2018-04-20)July 5, 2018 · Medical devices · Medical devices · Type III
- CardioMEMS Patient and Hospital Electronics System (2018-06-15)June 29, 2018 · Biologic or vaccine - Medical devices · Medical devices · Type III
- Perceval Sutureless Heart Valve (2018-06-21)June 29, 2018 · Medical devices · Medical devices · Type II
- NICO Shepherd's Hook (2018-06-11)June 29, 2018 · Medical devices · Medical devices · Type II
- qUAntify Control and qUAntify Plus Control (2018-06-18)June 29, 2018 · Medical devices · Medical devices · Type II
- CADD Solis VIP Infusion Pump (2018-06-11)June 29, 2018 · Medical devices · Medical devices · Type II
- proBNP II STAT Calset and proBNP II Calibrator (2018-06-14)June 29, 2018 · Medical devices · Medical devices · Type III
- 0-SPOT, S-SPOT, and TomoSPOT (2018-06-13)June 29, 2018 · Biologic or vaccine - Medical devices · Medical devices · Type II
- Minicon Clinical Sample Concentrators (B-15 & CS-15) (2018-06-11)June 29, 2018 · Medical devices · Medical devices · Type II
- BD Luer-Lok 10ml Syringe (2018-06-07)June 29, 2018 · Medical devices · Medical devices · Type II
- Universal Shears 7 1/2" (2018-06-13)June 29, 2018 · Medical devices · Medical devices · Type II
- MRSASelect and MRSASelect II (2018-06-13)June 29, 2018 · Medical devices · Medical devices · Type II
- StraightShot Microdebrider System XPS Blades (2018-05-30)June 29, 2018 · Medical devices · Medical devices · Type III
- Ceftriaxone 32 0.0002 ug/ml M.I.C.E (2018-06-01)June 29, 2018 · Medical devices · Medical devices · Type III
- Health Canada reminds Canadians of the limitations of fentanyl test strips being used to check street drugs before consumptionJune 22, 2018 · Consumer products - Medical devices · Product safety
- BD Vacutainer Push Button Blood Collection Set (2018-03-15)June 22, 2018 · Medical devices · Medical devices · Type II
- Dermatome An Handpiece (2018-06-12)June 22, 2018 · Medical devices · Medical devices · Type II
- NxStage System One Express Fluid Warmer (2018-06-11)June 22, 2018 · Medical devices · Medical devices · Type II
- BD Vacutainer Plus SST Tubes (2018-03-13)June 22, 2018 · Medical devices · Medical devices · Type II
- Arctic Sun 5000e Temperature Management System (2018-06-13)June 22, 2018 · Medical devices · Medical devices · Type II
- Paragon Oxygenator (2018-06-13)June 22, 2018 · Medical devices · Medical devices · Type II
- LIFECODES HLA-B SSO and HLA-B ERES SSO Typing Kit (2018-03-15)June 22, 2018 · Medical devices · Medical devices · Type III
- Signa 1.5T EXCITE HD - Magnet, Signa EXCOTE 3.0T G3 Magnet, Signa HDxt 1.5T MR System - Main Unit, Signa Infinity 1.5T TwinSpeed with Excite, 1.5T Signa HDx MR System - Main Unit (2018-06-07)June 22, 2018 · Medical devices · Medical devices · Type II
- VITROS Chemistry Products Na+ Slides (2018-06-06)June 22, 2018 · Medical devices · Medical devices · Type II
- Tina-Quant IGG Gen 2 (2018-06-07)June 22, 2018 · Medical devices · Medical devices · Type II
- RayStation, RayPlan, and InverseArc 1.0 (2018-06-06)June 22, 2018 · Medical devices · Medical devices · Type II
- Various Products from Olsen Medical, LLC (2018-05-11)June 22, 2018 · Medical devices · Medical devices · Type II
- Unify and Unify Assura, Fortify VR, DR, ST VR, ST DR, Assura VR, Assura DR Quadra Assura, Assura MP, and Unify Quadra Cardiac Resynchronization Device, Tiered-therapy Cardioverter/Defibrillator (2018-06-01)June 22, 2018 · Medical devices · Medical devices · Type II
- Biograph 6 - Main Unit and Biograph LSO 16 Slice PET (2018-05-16)June 22, 2018 · Medical devices · Medical devices · Type III
- Biograph mCT-S with TrueV (64) and TrueV (40), Biograph mCT-S (40) and (20), Biograph mCT Flow-3R, Flow-4R and Flow Edge-4R (2018-05-16)June 22, 2018 · Medical devices · Medical devices · Type III
- EXCOR Pediatric Ventricular Assist Device System - Blood Pumps and EXCOR System - Blood Pump PU Valves (2018-05-18)June 22, 2018 · Medical devices · Medical devices · Type II
- ABL90 FLEX - Analyzer (2018-05-07)June 22, 2018 · Medical devices · Medical devices · Type II
- BD MAX TNA MMK (SPC) (2018-05-04)June 22, 2018 · Medical devices · Medical devices · Type III
- Mobilediagnost WDR (2018-06-01)June 14, 2018 · Medical devices · Medical devices · Type II
- i-STAT CHEM8+ Cartridges and Controls (2018-06-05)June 14, 2018 · Medical devices · Medical devices · Type III
- Chemstrip 10A and Urisys 1100 Analyzer (2018-05-10)June 14, 2018 · Medical devices · Medical devices · Type II
- NeoMed Enteral Feeding Tubes with Enteral Only Connectors (2018-06-04)June 14, 2018 · Medical devices · Medical devices · Type III
- M320 Surgical Microscope (2018-05-18)June 14, 2018 · Medical devices · Medical devices · Type II
- Vectris SureScan MRI Leads and Vectris Trialing Leads (2018-05-24)June 14, 2018 · Medical devices · Medical devices · Type III
- Tapered Screw-Vent Implants with 0.5mm Machined Collar, MTX Surface and Microgrooves (2018-05-11)June 14, 2018 · Medical devices · Medical devices · Type III
- D-Special PROLENE Polypropylene Suture (2018-05-28)June 14, 2018 · Medical devices · Medical devices · Type II
- Heartmate 3 LVAS Implant Kit (2018-05-29)June 14, 2018 · Medical devices · Medical devices · Type II
- EMU40 White and EMU40EX (2018-05-16)June 14, 2018 · Medical devices · Medical devices · Type II
- Zeus Infinity Empowered (Anaesthesia Workstation) (2017-12-06)June 14, 2018 · Medical devices · Medical devices · Type III
- Prismatik Universal Low Fusing Ceramic Fluorescent Spray Glaze (2018-03-30)June 14, 2018 · Medical devices · Medical devices · Type III
- AMH (Anti-Müllerian Hormone) and Elecsys AMH (2018-04-30)June 14, 2018 · Medical devices · Medical devices · Type III
- ABBOTT PRISM HIV O Plus Assay Kit (2018-05-29)June 6, 2018 · Medical devices · Medical devices · Type III
- CORAIL Neck Trials (2018-05-29)June 6, 2018 · Medical devices · Medical devices · Type III
- Double Blade Shoe F/Unigraft Knife 1.5 Thick x 9mm (2018-04-02)June 6, 2018 · Medical devices · Medical devices · Type III
- Ball Tip Guide Wire Trauma Fixation Systems and Ball Time Guide Wire 2mm x 98cm Trauma Fixation systems (2018-05-28)June 6, 2018 · Medical devices · Medical devices · Type II
- Endo GIA Reload w/Tri-Staple Technology Med/Thick, Endo GIA Curved Tip Reload w/Tri-Staple Technology Vascular and Vascular/Medium, and Endo GIA Gray Articulating Reload Extra Thin/Vascular (2018-05-23)June 6, 2018 · Medical devices · Medical devices · Type I
- Symbia T series Gamma Camera/CT Scanners, Symbia Intevo and Symbia Intevo Bold (2018-05-16)June 6, 2018 · Medical devices · Medical devices · Type II
- Vanguard Knee System PS Tibial Bearing 11 mm 63/67 mm (2018-05-16)June 6, 2018 · Medical devices · Medical devices · Type II
- N Latex CDT (Carbohydrate-Deficient Transferrin) Kit (2018-05-24)June 6, 2018 · Medical devices · Medical devices · Type III
- Dimension Vista System - A1-Antitrypsin Assay (2018-05-22)June 6, 2018 · Medical devices · Medical devices · Type III
- Pressure Slave Cable (2018-05-15)June 6, 2018 · Medical devices · Medical devices · Type III
- CU-1000 Halogen Curing Light (2018-04-06)June 6, 2018 · Medical devices · Medical devices · Type II
- Power Express (2017-12-21)June 6, 2018 · Medical devices · Medical devices · Type III
- FACSLyric Instrument - FACS Universal Loading Option (2018-04-30)June 6, 2018 · Medical devices · Medical devices · Type III
- VITROS Chemistry Products PHYT Slides (2018-05-10)June 6, 2018 · Medical devices · Medical devices · Type II
- Liquid Assayed Specific Protein Controls (2018-05-09)June 1, 2018 · Medical devices · Medical devices · Type II
- VPS Rhythm ECG Accessory Pack with Johans Adapter and VPS TipTracker Stylet Accessory (2018-05-17)June 1, 2018 · Medical devices · Medical devices · Type III
- LFIT CoCr V40 Head and Femoral Head COCR LFIT (2018-05-24)June 1, 2018 · Medical devices · Medical devices · Type II
- Volista Surgical Lights (2018-05-24)June 1, 2018 · Medical devices · Medical devices · Type II
- Jasper Vektor Appliance (2018-05-09)June 1, 2018 · Medical devices · Medical devices · Type II
- Extracorporeal Tubing Set for Heart-Lung Machine - Perfusion Pack and Art.Cannula - Wire Reinforced, Straight Tip W/Ring, Pre-Mounted Connector (2018-05-07)June 1, 2018 · Medical devices · Medical devices · Type II
- Vantage Titan HSR (2018-05-09)June 1, 2018 · Medical devices · Medical devices · Type II
- VeriQ and VeriQ C System (2018-05-04)June 1, 2018 · Health products · Medical devices · Type II
- Heartware Ventricular Assist System- Controller/ Controller Kits, AC Adapter, DC Adapter, and Battery Pack (2018-05-07)June 1, 2018 · Health products · Medical devices · Type II
- AmniSure ROM Test Strips (2018-05-18)June 1, 2018 · Health products · Medical devices · Type II
- QuickFlip 3 - 2-Hole Plate Set, 2-Hole Plate/Burr Hole Cover, and Burr Hole Cover Set, Universal Neuro III - 2-Hole Plate Set, Self-Drilling Screw, 2-Hole Plate Set, With Tab, and Burr Hole Cover, Self-Drilling Screw (2018-05-14)June 1, 2018 · Health products · Medical devices · Type II
- HistoCore PELORIS 3 (2018-05-16)June 1, 2018 · Health products · Medical devices · Type III
- 17 Alpha-HydroxyProgesterone ELISA Kit (2018-05-04)June 1, 2018 · Health products · Medical devices · Type III
- Philips Xcelera and Intellispace Cardiovascular (ISCV) (2018-05-08)June 1, 2018 · Medical devices · Medical devices · Type III
- PRISMAFLEX Hemodialysis Unit, PRISMAFLEX with Software release 4.00, 5.00, 6.10, 7.10, 8.10 (2018-05-03)June 1, 2018 · Medical devices · Medical devices · Type III
- ARROW 3-Lumen, 8.5 Fr CVC Kits (2018-05-11)June 1, 2018 · Medical devices · Medical devices · Type II
- Liquidchek Urine Chemistry Control Niveau 2 (2018-05-11)June 1, 2018 · Medical devices · Medical devices · Type III
- Magna Pure 24 Instrument (2018-05-14)June 1, 2018 · Medical devices · Medical devices · Type II
- UniCel DxC 600i Synchron Access Clinical Systems and UniCel DxC 600 Access Immunoassay System with Dual Gantry (Class 2 and Class 3) (2018-05-15)May 25, 2018 · Medical devices · Medical devices · Type III
- CARDIOSAVE Intra-Aortic Balloon Pump (IABP) (2018-05-08)May 25, 2018 · Medical devices · Medical devices · Type II
- Equinox Relieve and Equinox Relieve II Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System (2018-05-07)May 25, 2018 · Medical devices · Medical devices · Type II
- SIGMA Spectrum Infusion Pump with Master Drug Library (2018-05-15)May 25, 2018 · Medical devices · Medical devices · Type II
- IACS Monitoring Solution with C500 and C700, and Infinity M540 (2018-02-28)May 25, 2018 · Medical devices · Medical devices · Type I
- Medline Industries' C-Section CDS Pack, Vaginal Delivery Pack - LF, OB Vaginal Pack-LF (2018-04-16)May 25, 2018 · Medical devices · Medical devices · Type III
- Sarns TCM II Cooling and Heating Systems (2018-04-06)May 25, 2018 · Medical devices · Medical devices · Type II
- HexaPOD evo Module (2018-05-14)May 25, 2018 · Medical devices · Medical devices · Type II
- Medi-Vac CRD Suction Canister System and Flex Advantage Kit (2018-05-08)May 25, 2018 · Medical devices · Medical devices · Type II
- Sysmex E-Check, EIGHTCHECK 3WP XTRA, SYSMEX SCS-1000, XN CHECK, XN CAL, XN CAL PF, XN CAL - CUSTOMER SET, XN CAL PF - CUSTOMER SET, XN-L CHECK (2018-05-08)May 25, 2018 · Medical devices · Medical devices · Type III
- ORTHO VISION Analyzer and ORTHO VISION Max Analyzer (2018-05-04)May 25, 2018 · Medical devices · Medical devices · Type II
- P.R.O. Matt Plus (2018-05-04)May 25, 2018 · Medical devices · Medical devices · Type II
- CEREC AC with CEREC Ominicam (2018-05-15)May 25, 2018 · Medical devices · Medical devices · Type II
- Dimension Vista System - Gentamicin Assay, Dimension Clinical Chemistry System - Gentamicin, Dimension Xpand System - Genamicin (Gent) Assay, Dimension EXL System Gentamicin (Gent) Assay (2018-04-24)May 25, 2018 · Medical devices · Medical devices · Type III
- Drill Sleeve Guide (2018-05-02)May 25, 2018 · Medical devices · Medical devices · Type II
- Interactive Implant (2018-03-16)May 25, 2018 · Medical devices · Medical devices · Type II
- AVENIO Millisect instrument Base and PC (2018-04-03)May 25, 2018 · Medical devices · Medical devices · Type III
- Accu-Chek Inform II Test Strips (2018-05-07)May 25, 2018 · Medical devices · Medical devices · Type II
- Accu-Chek Aviva Test Strips (2018-05-07)May 25, 2018 · Medical devices · Medical devices · Type II
- Infusomat Space Pump Sets with Anti-Siphon Valve (2018-05-04)May 18, 2018 · Biologic or vaccine - Medical devices · Medical devices · Type II
- Philips OmniDiagnost and OmniDiagnost Eleva (2018-05-07)May 18, 2018 · Medical devices · Medical devices · Type II
- Heartstart XL, Heartstart MRX Defibrillator/Monitor and Heartstart XL+ (2018-04-18)May 18, 2018 · Medical devices · Medical devices · Type II
- HARMONIC ACE+ Shears with Adaptive Tissue Technology, 23 cm and 36 cm (2018-05-08)May 18, 2018 · Medical devices · Medical devices · Type II
- SAM XT Extremity Tourniquet Tactical Black (PN SAM XT-M), SAM XT Extremity Tourniquet Hi-Viz Orange (PN SAM XT-C) and SAM XT Extremity Tourniquet Hi-Viz Blue (PN SAM XT-B) (2018-05-01)May 18, 2018 · Medical devices · Medical devices · Type II
- da Vinci Xi EndoWrist Stapler 45 Reload (2018-04-27)May 18, 2018 · Medical devices · Medical devices · Type II
- Dräger Jaundice Meter JM-103 and JM-105 (2018-05-09)May 18, 2018 · Medical devices · Medical devices · Type I
- Coombs lgG and LISS/Coombs for Indirect Antiglobulin Testing (IAT) (2018-04-30)May 18, 2018 · Medical devices · Medical devices · Type III
- Cardinal Healths' Sterile Obstetrical Pack, Pack Prostate Rad and Pack Uteroscopy (2018-04-24)May 18, 2018 · Medical devices · Medical devices · Type II
- AirLife Arterial Blood Gas (ABG) Sampling Syringes, Aspirators and Kits (2018-04-23)May 18, 2018 · Medical devices · Medical devices · Type III
- Sterile 0.9% Sodium Chloride and Sterile Water For Irrigation (2018-04-02)May 18, 2018 · Medical devices · Medical devices · Type III
- Elecsys Vitamin D total II (2018-04-25)May 18, 2018 · Medical devices · Medical devices · Type II
- IntraClude Intra-aortic Occlusion Device (2018-04-02)May 18, 2018 · Medical devices · Medical devices · Type II
- Alaris Pump Administration Sets (2018-04-17)May 11, 2018 · Medical devices · Medical devices · Type III
- Centeze Centesis Catheter (2018-05-01)May 11, 2018 · Medical devices · Medical devices · Type I
- Collision Ring System on IMRIS iMRI 3T S (2018-04-04)May 11, 2018 · Medical devices · Medical devices · Type II
- Reusable Active Cord (2018-04-24)May 11, 2018 · Medical devices · Medical devices · Type II
- Artis Zeego Multi-Axis, Artis Zee Floor, Artis ceiling, Artis zee biplane (2018-04-27)May 11, 2018 · Medical devices · Medical devices · Type II
- Heparin Lock Syringe and Flush Syringe (2018-04-13)May 11, 2018 · Medical devices · Medical devices · Type II
- Cobas PCR Media Dual Swab Sample Kit (2018-02-14)May 11, 2018 · Medical devices · Medical devices · Type III
- Immulite System Anti-TG Ab and Immulite 1000 System - Thyroid Autoantibody Assay Anti-TG Ab (2018-04-25)May 11, 2018 · Medical devices · Medical devices · Type III
- Covidien Endo GIA Articulating Loading Units (2018-04-26)May 11, 2018 · Medical devices · Medical devices · Type I
- Percutaneous Sheath Introducer Procedural Kits with Silk Sutures (2018-04-13)May 11, 2018 · Medical devices · Medical devices · Type II
- Alice 6 PSG System (2018-03-16)May 11, 2018 · Medical devices · Medical devices · Type III
- Reprocessed EP Catheter (2018-03-29)May 11, 2018 · Medical devices · Medical devices · Type II
- BD Pre-Filled Normal Saline Syringe (2018-04-20)May 11, 2018 · Medical devices · Medical devices · Type II
- IMMULITE System and 1000 System - Turbo Intact PTH Assay (2018-03-26)May 11, 2018 · Medical devices · Medical devices · Type III
- Various ID-MTS Gel Cards products (2018-04-25)May 4, 2018 · Medical devices · Medical devices · Type III
- T2 Ankle Arthrodesis Nail, IEFT, Non-Sterile, T2 Femur System - Femoral Nails, T2 Tibial Nail System - Nail Standard (Sterile) and T2 Recon Nail System - Titanium (2018-04-24)May 4, 2018 · Medical devices · Medical devices · Type I
- Alaris Pump Module Model 8100 (2018-04-10)May 4, 2018 · Medical devices · Medical devices · Type II
- BD Vacutainer Heparin and EDTA Tubes (2018-04-06)May 4, 2018 · Medical devices · Medical devices · Type II
- VOLISTA StandOP and TRIOP Surgical Lights (2018-04-04)May 4, 2018 · Medical devices · Medical devices · Type II
- Biograph mMR System (2018-04-18)May 4, 2018 · Medical devices · Medical devices · Type II
- Various Medlines' Custom Procedure Packs (2018-04-06)May 4, 2018 · Medical devices · Medical devices · Type III
- Milford Smartbase (2018-03-27)May 4, 2018 · Medical devices · Medical devices · Type II
- Power Express Line Computer Software (2018-03-29)May 4, 2018 · Medical devices · Medical devices · Type III
- Sterile C Section Pack, Bone Marrow Tray, Sterile Labour and Delivery Pack, Sterile Obstetrical Pack, Sterile Delivery Pack, and Bone Marrow Biopsy Pack from Cardinal Health (2018-04-17)May 1, 2018 · Medical devices · Medical devices · Type II
- LMA StoneBreaker Intracorporeal Lithotripter System and StoneBreaker System - Pneumatic Lithotripter (2018-03-13)May 1, 2018 · Medical devices · Medical devices · Type II
- Comprehensive Shoulder System Primary Mini and Primary Length Shoulder Stem (2017-12-21)May 1, 2018 · Medical devices · Medical devices · Type II
- ADIVA 120 System - DIFF TIMEpac, ADVIA 2120I Hematology System - DIFF TIMEpac and ADVIA 2120 Hematology System - DIFF TIMEpac (2018-04-10)May 1, 2018 · Medical devices · Medical devices · Type III
- Cobas MPX (2018-04-13)May 1, 2018 · Medical devices · Medical devices · Type III
- ADVIA Chemistry System - Urea Nitrogen (UN) Assay (2018-04-05)May 1, 2018 · Medical devices · Medical devices · Type II
- SpatialFrame.com Software (2018-03-19)May 1, 2018 · Medical devices · Medical devices · Type II
- BD Vacutainer Plus Plastic Citrate Tube (2018-04-04)May 1, 2018 · Medical devices · Medical devices · Type II
- neoBLUE mini LED Phototherapy System, neoBLUE LED Therapy Device, neoBLUE Cozy, Blanket, and Compact LED Phototherapy System (2018-04-08)May 1, 2018 · Medical devices · Medical devices · Type III
- Floor Mount Fasteners Dual PLTS and Wall Mount Cot Fasteners (2018-04-05)May 1, 2018 · Medical devices · Medical devices · Type III
- EEA Hemorrhoid and Prolapse Stapler Set with DST (2018-04-09)May 1, 2018 · Medical devices · Medical devices · Type II
- HeartMate III LVAS Implant Kit (2018-04-05)May 1, 2018 · Medical devices · Medical devices · Type II
- Cobalt Chrome Modular Head Component and 36mm Modular Head (2018-04-11)May 1, 2018 · Medical devices · Medical devices · Type II
- Synthes Flex Arm (2018-03-21)May 1, 2018 · Medical devices · Medical devices · Type III
- Dimension Vista System - Multi 1 Sample Diluent (MULTI 1 SDIL) and Multi 2 Sample Diluent (MULTI 2 SDIL), CTNI Sample Diluent (CITNI SDIL) (2018-03-26)May 1, 2018 · Medical devices · Medical devices · Type III
- 5mm ENDOPATH XCEL Bladeless Trocars with Stability Sleeve and 5mm ENDOPATH XCEL with OPTIVIEW Technology Universal Trocar Stability Sleeve (2018-03-26)May 1, 2018 · Medical devices · Medical devices · Type III
- Azurion 7 M12 and Azurion 7 M20 (2018-03-19)May 1, 2018 · Medical devices · Medical devices · Type II
- K-Wire (Trocar Point) (2018-03-13)April 24, 2018 · Medical devices · Medical devices · Type III
- Echo Bi-Metric Collarless Porous Stem, Size 7 (2017-12-28)April 24, 2018 · Medical devices · Medical devices · Type II
- F.O. SP Laryngoscope handle (2018-04-11)April 24, 2018 · Medical devices · Medical devices · Type II
- K-SOFT Embryo Transfer Catheter Set (2018-04-09)April 24, 2018 · Medical devices · Medical devices · Type II
- Blom-Singer Plug Inserts (2018-03-26)April 24, 2018 · Medical devices · Medical devices · Type II
- Instrument Manager (2018-04-16)April 24, 2018 · Medical devices · Medical devices · Type II
- Sciatic Nerve Retractor (and Long) (2018-04-03)April 24, 2018 · Medical devices · Medical devices · Type II
- Various Guide Wire products from Zimmer Inc. (2018-04-05)April 24, 2018 · Medical devices · Medical devices · Type II
- Allura XPER Systems (2018-03-19)April 24, 2018 · Medical devices · Medical devices · Type II
- Brilliance 6/10/16 Slice CT System (2018-04-02)April 24, 2018 · Medical devices · Medical devices · Type II
- T2100 Treadmill (2018-04-02)April 24, 2018 · Medical devices · Medical devices · Type II
- Spectra Optia Apheresis System (2018-04-03)April 24, 2018 · Medical devices · Medical devices · Type II
- MultiDiagnost Eleva - Image Intensifier - TV Image Detector and Flat Detector - Image Detector (2018-03-29)April 24, 2018 · Medical devices · Medical devices · Type II
- Vivid 7 Dimension Ultrasound System, Vivid E9 Ultrasound System, Vivid E95 and Vivid E90 (2018-03-28)April 24, 2018 · Medical devices · Medical devices · Type II
- LOGIC 9 and LOGIQ E9 General Purpose Ultrasound System (2018-03-28)April 24, 2018 · Medical devices · Medical devices · Type II
- On-X Conform-X Prosthetic Heart Valve - Aortic with Extended Valve Holder, Mitral, Aortic and On-X Prosthetic Heart Valve - Aortic, Mitral, On-X Prosthetic Heart Valve - Aortic with Extended Valve Holder, and On-X Aortic Prosthetic Heart Valve with A...April 24, 2018 · Medical devices · Type II
- Coulter DxH Cleaner (2017-12-04)April 24, 2018 · Medical devices · Medical devices · Type III
- Allen Bow Frame, A-70800 (2017-10-27)April 24, 2018 · Medical devices · Medical devices · Type II
- Cobas e801 Syringes (2018-03-23)April 24, 2018 · Medical devices · Medical devices · Type II
- Monoclonal Mouse Anti-Pneumocystis Jiroveci, Clone 3F6 and Monoclonal Mouse Ant-Human Leukemia, Hairy Cell Clone DBA.44 (2018-03-23)April 24, 2018 · Medical devices · Medical devices · Type II
- Contact Matrix Plus and Contact Ring Refill (2018-03-09)April 24, 2018 · Medical devices · Medical devices · Type III
- Zimmer Segmental System Proximal Femoral Component (2018-04-18)April 18, 2018 · Medical devices · Medical devices · Type II
- Percutaneous Radiofrequency Ablation Catheter and the Potential Risk of Atrioesophageal FistulaApril 16, 2018 · Medical devices · Medical devices
- Various products from Medos International Sàrl (2018-03-01)April 13, 2018 · Medical devices · Medical devices · Type II
- LEGION CR High Flex XLPE SZ 5-6 11mm (2018-04-03)April 13, 2018 · Medical devices · Medical devices · Type II
- Xper Flex Cardio Physiomonitoring System-Main Unit (2018-03-13)April 13, 2018 · Medical devices · Medical devices · Type II
- SHOEBOX Audiometry Pro (2018-03-26)April 13, 2018 · Medical devices · Medical devices · Type III
- Lunar Prodigy (2018-03-20)April 13, 2018 · Medical devices · Medical devices · Type II
- 3.5mm Inserter Connector, Short Trauma Fixation Systems (2018-03-23)April 13, 2018 · Medical devices · Medical devices · Type II
- Gentle Threads Interference Screws PLGA Full Thread (2018-04-09)April 13, 2018 · Medical devices · Medical devices · Type II
- Infinity M540 (2018-03-19)April 13, 2018 · Medical devices · Medical devices · Type I
- EMS Power-LOAD (2018-03-12)April 13, 2018 · Medical devices · Medical devices · Type I
- TEM Tube Set, single-use item, sterile (2018-03-26)April 13, 2018 · Medical devices · Medical devices · Type II
- One-Way Valve Connector (2018-03-27)April 13, 2018 · Medical devices · Medical devices · Type I
- CooperSurgical Apple-Hunt Secondary Cannula (2018-03-19)April 13, 2018 · Medical devices · Medical devices · Type III
- Achieva and Intera 1.5T MRI System - Main Unit (2018-03-22)April 13, 2018 · Medical devices · Medical devices · Type II
- SERVO-i Ventilator System (2018-03-20)April 13, 2018 · Medical devices · Medical devices · Type II
- 432-RPK-01 LONG-TERM DIALYSIS REPAIR KIT (2018-02-23)April 6, 2018 · Medical devices · Medical devices · Type II
- Edwards PASCAL Transcatheter Mitral Valve Repair System - Guide Sheath (2018-03-05)April 6, 2018 · Medical devices · Medical devices · Type II
- Thermo Scientific Oxoid Mueller Hinton Broth (2018-03-07)April 6, 2018 · Medical devices · Medical devices · Type II
- DxTerity Diagnostic Catheter (2018-02-07)April 6, 2018 · Medical devices · Medical devices · Type III
- IH-1000 (2018-03-13)April 6, 2018 · Medical devices · Medical devices · Type II
- HeartWare Ventricular Assist System (2018-03-22)April 6, 2018 · Medical devices · Medical devices · Type I
- Remipack (2018-03-28)April 6, 2018 · Medical devices · Medical devices · Type I
- WaveOne Gold Reciprocating Files (2018-03-19)April 3, 2018 · Medical devices · Medical devices · Type II
- Sonopet Main Unit, Universal, and Universal Handpiece (2018-03-12)April 3, 2018 · Medical devices · Medical devices · Type III
- Optilite Beta-2-microglobulin Urine Kit (2018-03-09)April 3, 2018 · Medical devices · Medical devices · Type II
- Sternal Valve Retractor with Atrial and Aortic Attachments (2018-03-05)April 3, 2018 · Medical devices · Medical devices · Type II
- Neisseria meningitidis Poly A-D (2018-02-28)April 3, 2018 · Medical devices · Medical devices · Type III
- F&P SleepStyle CPAP Device (2018-03-14)April 3, 2018 · Medical devices · Medical devices · Type III
- Galileo Echo Instrument (2018-03-07)April 3, 2018 · Medical devices · Medical devices · Type III
- iChemVELOCITY Automated Urine Chemistry System - with Load/Unload and Back Integrated, iRICELL1000 Plus, iRICELL2000 Plus and Pro, iRICELL3000 Plus and Pro (2018-02-26)April 3, 2018 · Medical devices · Medical devices · Type II
- Hoffmann LRF-Hinge Coupling (2018-03-02)April 3, 2018 · Medical devices · Medical devices · Type III
- IBDoc Calprotectin Kit, Starter Kit and CalApp (2018-02-27)April 3, 2018 · Medical devices · Medical devices · Type II
- iQ200 Sprint and Elite Automated Urine Microscopy Analyzer, iQ200 Select Urinanlysis System - Analyzer, iQ200 Elite Plus and Pro, iQ Select Plus and Pro, iQ Sprint Plus and Pro (2018-02-26)April 3, 2018 · Medical devices · Medical devices · Type II
- VITEK 2 Compact 30 System - Instrument (2017-03-02)April 3, 2018 · Medical devices · Medical devices · Type II
- InterActive Healing Collar (2018-03-16)April 3, 2018 · Medical devices · Medical devices · Type II
- TDWorkstation (2018-02-03)April 3, 2018 · Medical devices · Medical devices · Type II
- Platinium DFR VR ICD, DR ICD, and SonR CRT-D (2018-03-16)March 23, 2018 · Medical devices · Medical devices · Type II
- LIFECODES HLA-DRB1 SSO, HLA-DQA1/B1 SSO, and HLA-DPA/B1 SSO Typing Kit (2017-07-07)March 23, 2018 · Medical devices · Medical devices · Type III
- COOK Vacuum Pump and Aspiration Unit (2018-03-01)March 23, 2018 · Medical devices · Medical devices · Type II
- Alinity C and I Processing Module (2018-02-22)March 23, 2018 · Medical devices · Medical devices · Type II
- Comprehensive Segmental Revision System (SRS)/Discovery Distal Body with Screw 50mm-70mm (2018-03-13)March 23, 2018 · Medical devices · Medical devices · Type II
- Graphic Cases for 6.5 mm and 7.3 mm Cannulated Screw Sets (2018-03-06)March 23, 2018 · Medical devices · Medical devices · Type III
- CADD Blue-Striped Administration Set (2018-02-28)March 23, 2018 · Medical devices · Medical devices · Type II
- Biograph MMR System (2018-01-26)March 23, 2018 · Medical devices · Medical devices · Type III
- ZYMUTEST HIA IgGAM MonoStrip (2018-02-06)March 23, 2018 · Medical devices · Medical devices · Type III
- SKYN Cocktail Club Polyisoprene Male Condoms (2018-03-05)March 23, 2018 · Medical devices · Medical devices · Type III
- Elecsys T3 (2018-02-28)March 23, 2018 · Medical devices · Medical devices · Type III
- BC-3200 and BC-3600 Auto Hematology Analyzer - Diluent M-30D (2018-02-28)March 23, 2018 · Medical devices · Medical devices · Type II
- Solus Flexible Laryngeal Mask Airways (2017-04-05)March 23, 2018 · Medical devices · Medical devices · Type II
- 1 mL Medallion Syringe (2018-02-08)March 23, 2018 · Medical devices · Medical devices · Type II
- ScaleTronix Oversized Wheelchair Scales (2018-02-27)March 23, 2018 · Medical devices · Medical devices · Type III
- VITEK 2 Companct 30 System - Instrument (2018-02-22)March 23, 2018 · Medical devices · Medical devices · Type II
- Capio and Capio SLIM Suture Capturing Device, Uphold Vaginal Support System, Uphold LITE with Capio SLIM, and Pinnacle Pelvic Floor Repair Kit - Posterior (2018-02-15)March 23, 2018 · Medical devices · Medical devices · Type II
- RX Daytona System Lipase and Lipase (LPS) (2018-02-28)March 21, 2018 · Medical devices · Medical devices · Type II
- Cardinal Healths' Presource Kits (2018-03-06)March 21, 2018 · Medical devices · Medical devices · Type II
- BRILLIANCE SALMONELLA AGAR (2018-03-01)March 21, 2018 · Medical devices · Medical devices · Type III
- Clarity ADVANCED Ceramic Brackets with APC Flash-Free Adhesive (2018-01-25)March 21, 2018 · Medical devices · Medical devices · Type II
- ADVIA Centaur and ADVIA Centaur CP System - Creatine Kinase-MB (CKMB) Assay (2018-02-28)March 19, 2018 · Medical devices · Medical devices · Type III
- ADVIA Centaur and ADVIA Centaur CP System - CA 125 II Assay (2018-02-23)March 19, 2018 · Medical devices · Medical devices · Type III
- ME4 (SLEEK) (2018-02-20)March 19, 2018 · Medical devices · Medical devices · Type III
- Centricity PACS-IW (2018-02-23)March 19, 2018 · Medical devices · Medical devices · Type II
- MATCH IT! DNA Software (2018-02-11)March 19, 2018 · Medical devices · Medical devices · Type II
- Victory Series Low Profile Bracket with APC PLUS Adhesive (2018-01-25)March 19, 2018 · Medical devices · Medical devices · Type II
- TRUShape 3D Conforming Files (2018-02-02)March 19, 2018 · Medical devices · Medical devices · Type II
- SOMATOM Emotion 16 - Tomography Scanner (2018-02-05)March 19, 2018 · Medical devices · Medical devices · Type II
- IMRIS Operating Room Table Model T2X, ORT100, and ORT300 (2018-02-20)March 19, 2018 · Medical devices · Medical devices · Type II
- SOMATOM Sensation Open, Sensation 4, Emotion Duo, Sensation 16 System - Main Unit, and Sensation/Cardiac 64 (2018-02-05)March 19, 2018 · Medical devices · Medical devices · Type II
- Ultrafilter U9000 (2018-02-27)March 19, 2018 · Medical devices · Medical devices · Type II
- True 3D Viewer (2018-02-21)March 13, 2018 · Medical devices · Medical devices · Type III
- Rheumatoid Factor (RF) Latex test (2018-02-20)March 13, 2018 · Medical devices · Medical devices · Type III
- Alinity ci-series System Control Module (2018-02-26)March 13, 2018 · Medical devices · Medical devices · Type III
- Philips HeartStart OnSite and Home Defibrillator and HeartStart FRx Automated External Defibrillator (2018-02-23)March 13, 2018 · Medical devices · Medical devices · Type II
- System 83 (+) Plus (2018-02-27)March 13, 2018 · Medical devices · Medical devices · Type II
- ExactaMed Oral Dispensers, 5 mL (2018-02-09)March 13, 2018 · Medical devices · Medical devices · Type II
- HemosIL Factor XII Deficient Plasma (2017-07-17)March 13, 2018 · Medical devices · Medical devices · Type III
- GEN11 Generator System - Main Unit (2018-02-20)March 13, 2018 · Medical devices · Medical devices · Type III
- Homocysteine Calibrator (2018-02-22)March 13, 2018 · Medical devices · Medical devices · Type III
- 3M Surgical Clipper Professional (2018-02-14)March 13, 2018 · Medical devices · Medical devices · Type III
- Somatom Emotion 16-Slice Configuration and Somatom Perspective - CT Scanner (2018-02-05)March 13, 2018 · Medical devices · Medical devices · Type II
- RayStation and RayPlan (2018-01-26)March 13, 2018 · Medical devices · Medical devices · Type III
- Brilliance CT Big Bore System-Main Unit, Brilliance ICT System - System, Brilliance ICT SP System - Main and Ingenuity CT System (2018-02-14)March 13, 2018 · Medical devices · Medical devices · Type II
- Electrosurgical Generator (2017-08-18)March 13, 2018 · Medical devices · Medical devices · Type III
- Bovie Medicals' J-Plasma Handpiece, Blade Tip, Pistol Grip (2018-02-08)March 13, 2018 · Medical devices · Medical devices · Type II
- Conserve Plus Thick Cups and Shell (2018-01-11)March 13, 2018 · Medical devices · Medical devices · Type III
- MYLAB 70 X Vision and XVG, MYLAB TWICE and CLASS C (2018-01-22)March 13, 2018 · Medical devices · Medical devices · Type II
- Unauthorized injectable drugs and medical devices seized from Revoskin in Vancouver, B.C., may pose serious health risksMarch 7, 2018 · Drugs - Medical devices
- Halyard Closed Suction and Turbo-Cleaning Closed Suction System for Adults, Double Swivel Elbow (DSE) (2018-02-07)March 6, 2018 · Medical devices · Medical devices · Type I
- Osscora Surgical Set (2018-02-14)March 2, 2018 · Medical devices · Medical devices · Type III
- AlterG M320 (2018-02-09)March 2, 2018 · Medical devices · Medical devices · Type II
- AQUIOS CL Flow Cytometer System (2018-01-29)March 2, 2018 · Medical devices · Medical devices · Type I
- ADVIA Centaur CP System - Procalcitionin (PCT) Assay and ADVIA Centaur System - Procalcitionin (PCT) Assay (2018-02-13)March 2, 2018 · Medical devices · Medical devices · Type III
- Infiniti Bracket (sold as part of CIVCO brand Biopsy Starter Kits and Biopsy Bracket) (2018-02-26)March 2, 2018 · Medical devices · Medical devices · Type II
- Classic Sterisorb sterile Absorbent Pad (Ultra and Optimum) (2018-01-29)March 2, 2018 · Medical devices · Medical devices · Type II
- BIOCAL 370 Temperature Controller (2018-02-08)March 2, 2018 · Medical devices · Medical devices · Type II
- Bair Hugger Full Access Underbody Blanket (2018-02-02)March 2, 2018 · Medical devices · Medical devices · Type III
- Wet-Field Coagulator (2018-02-09)February 22, 2018 · Medical devices · Medical devices · Type III
- NANOCLAVE EXT SET (2018-02-01)February 22, 2018 · Medical devices · Medical devices · Type II
- VIDAS SYSTEM - Analyzer Class 3 and miniVIDAS Analyzer (2018-01-10)February 22, 2018 · Medical devices · Medical devices · Type II
- Philips AVENT Smart Ear Thermometer (2018-01-25)February 22, 2018 · Medical devices · Medical devices · Type II
- PENTAX Video Duodenoscope (2018-02-20)February 22, 2018 · Medical devices · Medical devices · Type II
- MYLAB70 XVISION and ULTRASOUND SYSTEM - Main Unit, MYLAB TWICE and MYLAB CLASS C (2018-01-03)February 22, 2018 · Medical devices · Medical devices · Type II
- VisuLize Factor VIII Antigen Kit (2018-02-13)February 22, 2018 · Medical devices · Medical devices · Type II
- MiSeqDx Cystic Fibrosis 139-Variant Assay (2018-02-13)February 22, 2018 · Medical devices · Medical devices · Type III
- Barrx 360 Express RFA Balloon Catheter (2018-02-08)February 22, 2018 · Medical devices · Medical devices · Type II
- Cobas 6500 - Cobas U Cuvette (2017-09-14)February 22, 2018 · Medical devices · Medical devices · Type II
- ExacTrac Patient Positioning System (2018-01-25)February 16, 2018 · Medical devices · Medical devices · Type II
- Triathlon Total Knee System - Tibial Augment (2018-02-02)February 16, 2018 · Medical devices · Medical devices · Type III
- Berchtold Chromophare Ceiling Mounted Surgical Light System (2018-02-02)February 16, 2018 · Medical devices · Medical devices · Type II
- Salivary Cortisol ELISA (2018-02-02)February 16, 2018 · Medical devices · Medical devices · Type III
- Centricity Universal Viewer - Main Unit (2018-02-06)February 16, 2018 · Medical devices · Medical devices · Type II
- ORBIT INCISOR Plus (2018-02-02)February 16, 2018 · Medical devices · Medical devices · Type II
- Tensor Sport Antimicrobial Deluxe Ankle Brace (2018-01-30)February 16, 2018 · Medical devices · Medical devices · Type III
- ACUSON SC2000 PRIME Ultrasound System - Mainframe (2018-01-31)February 16, 2018 · Medical devices · Medical devices · Type II
- Stage 1 Tissue Punch (2018-01-31)February 16, 2018 · Medical devices · Medical devices · Type III
- ARTIS Q and Zee Ceiling (2018-02-02)February 16, 2018 · Medical devices · Medical devices · Type III
- Panther and Panther Fusion System (2018-01-17)February 16, 2018 · Medical devices · Medical devices · Type II
- OrthoScan HD Model 1000 Mini C-Arm X-Ray System and OrthoScan Mobile DI Mini C-Arm X-Ray System (2018-02-05)February 9, 2018 · Medical devices · Medical devices · Type II
- Reprocessed Diagnostic Electrophysiology (EP) Catheters (2018-01-25)February 9, 2018 · Medical devices · Medical devices · Type II
- Electsys ANTI-HAV (2018-01-23)February 9, 2018 · Medical devices · Medical devices · Type III
- Cocaine Metabolite Micro-Plate EIA (2018-01-16)February 9, 2018 · Medical devices · Medical devices · Type III
- Bio-Kinetix Thermal Archwire (2018-01-15)February 9, 2018 · Medical devices · Medical devices · Type III
- Medfusion Syringe Pump Model Series 3500 and 4000 (2018-01-04)February 9, 2018 · Medical devices · Medical devices · Type II
- Berchtold Chromophare Ceiling Mounted Surgical Light System (2018-01-29)February 9, 2018 · Medical devices · Medical devices · Type II
- Various Associated Health Systems Products (2018-01-22)February 9, 2018 · Medical devices · Medical devices · Type II
- AutoMate 2500 Family (2018-01-12)February 9, 2018 · Medical devices · Medical devices · Type II
- Trillium Affinity and Affinity NT Cardiotomy/Venous Reservoir (CVR) (2018-01-16)February 9, 2018 · Medical devices · Medical devices · Type II
- HeartStart MRx Defibrillator/Monitor, HeartStart MRx Defibrillator/Monitor with Q-CPR, QCPR - CPR Meter, and QCPR - CPR Meter Upgrade Kit (2018-01-25)February 9, 2018 · Medical devices · Medical devices · Type II
- Carescape R860 (2017-12-13)February 9, 2018 · Medical devices · Medical devices · Type II
- Panocell-10, Ficin Treated (2018-01-30)February 9, 2018 · Medical devices · Medical devices · Type III
- ETEST Antimicrobial Susceptibility Testing - Polymyxin B (2017-01-23)February 6, 2018 · Medical devices · Medical devices · Type I
- GeneXpert Dx System - Xpert MRSA Assay (2017-11-28)February 1, 2018 · Medical devices · Medical devices · Type II
- Cobus 6500 u601 Urinalysis System - Urine Analyzer and Cobus 6500 u701 Microscopy Analyzer (2018-01-15)February 1, 2018 · Medical devices · Medical devices · Type II
- Milling Handpiece (2016-10-06)February 1, 2018 · Medical devices · Medical devices · Type II
- VITROS Immunodiagnostic Products TSH Reagent Pack (2018-01-15)February 1, 2018 · Medical devices · Medical devices · Type III
- Cortisol Saliva Luminescence Immunoassay (2018-01-12)February 1, 2018 · Medical devices · Medical devices · Type III
- System DI-60 Main Unit and Remote Review Software (2018-01-23)February 1, 2018 · Medical devices · Medical devices · Type III
- Xpert GBS Assay (2017-12-08)February 1, 2018 · Medical devices · Medical devices · Type II
- Automate 2550 and 1250, Aliquotter Tip Present Sensor (2018-01-16)February 1, 2018 · Medical devices · Medical devices · Type II
- BD Phoenix System - NMIC 1 and NMIC 93 (2018-01-09)February 1, 2018 · Medical devices · Medical devices · Type II
- Dimension Xpand System - Xpand Plus Basic Analyzer (Class 2 and 3), Xpand Plus with HM Analyzer (Class 2 and 3) and Dimension EXL 200 Analyzer (2018-01-16)February 1, 2018 · Medical devices · Medical devices · Type III
- PDS Plus Antibacterial (polydioxanone) Suture (2018-01-09)February 1, 2018 · Medical devices · Medical devices · Type III
- CORE 2 Console (2018-01-12)January 29, 2018 · Medical devices · Medical devices · Type III
- Progressa (Frame) (2018-01-12)January 29, 2018 · Medical devices · Medical devices · Type II
- Over-Pressure Safety Valve (2018-01-08)January 29, 2018 · Medical devices · Medical devices · Type II
- ADIVA Centaur CP System - Folate (FOL), Folate, Cyclosporine (CSA), HBC IGM (AHBCM), DHEA-SO4 (DHEA-S) Assay and ADIVA Centaur System - HBC IGM (AHBCM), DHEA-SO4 (DHEA-S) Assay (2018-01-05)January 29, 2018 · Medical devices · Medical devices · Type III
- Lung Transplant Kit TGH (2018-01-12)January 29, 2018 · Medical devices · Medical devices · Type II
- ALLURA XPER FD10/10 - Main Unit, FD20/10 System-Main Unit, FD20/20, FD10, FD20 System - Main Unit, FD20 Or Table (2017-12-28)January 29, 2018 · Medical devices · Medical devices · Type II
- LikoGuard L and LikoGuard XL (2017-12-18)January 29, 2018 · Medical devices · Medical devices · Type III
- i-STAT Alinity Instrument with Analyzer Software (2017-12-21)January 29, 2018 · Medical devices · Medical devices · Type III
- Phadia 250 Instrument (including software) (2017-11-29)January 29, 2018 · Medical devices · Medical devices · Type II
- ACCOLADE Pacemaker, MRI Pacemaker, VISIONIST CRT-P and X4 CRT-P (2017-12-19)January 29, 2018 · Medical devices · Medical devices · Type II
- XN CHECK (2018-01-04)January 29, 2018 · Medical devices · Medical devices · Type III
- Revitan Modular Rasp Distal Curved and Revitan Rasp Distal Curved (2017-12-27)January 29, 2018 · Medical devices · Medical devices · Type II
- Joerns UltraCare XT Bed (2018-01-12)January 29, 2018 · Medical devices · Medical devices · Type II
- VISIONIST CRT-P, X4 CRT-P and Autogen CRT-D (2017-12-19)January 29, 2018 · Medical devices · Medical devices · Type II
- SpyScope DS Access and Delivery Catheter (2017-12-20)January 29, 2018 · Medical devices · Medical devices · Type II
- Leica PROVEO 8 Ophthalmic Microscope System (2017-09-25)January 29, 2018 · Medical devices · Medical devices · Type III
- SYNGO.VIA (2018-01-11)January 29, 2018 · Medical devices · Medical devices · Type III
- Reprocessed LASSO 2515 NAV eco Variable Catheter (2018-01-02)January 29, 2018 · Medical devices · Medical devices · Type II
- ProGrade (2018-01-16)January 29, 2018 · Medical devices · Medical devices · Type II
- Elecsys DHEA-S (2018-01-05)January 29, 2018 · Medical devices · Medical devices · Type III
- Challenger Ligature and Marking Clips, DS Clip Appliers (2018-01-16)January 29, 2018 · Medical devices · Medical devices · Type II
- IntelliVue Information CenteriX - Software (2018-01-08)January 29, 2018 · Medical devices · Medical devices · Type II
- Elements Obturation Unit (2017-12-28)January 29, 2018 · Medical devices · Medical devices · Type II
- Volista Surgical Lights (2018-01-08)January 29, 2018 · Medical devices · Medical devices · Type II
- Trabecular Metal Primary Hip Prosthesis Femoral Stem 128mm Stem Length Standard and Extended Offset (2018-01-10)January 29, 2018 · Medical devices · Medical devices · Type III
- RADREX-i (2017-12-19)January 29, 2018 · Medical devices · Medical devices · Type II
- Brilliance CT Big Bore System-Main Unit (2018-01-05)January 29, 2018 · Medical devices · Medical devices · Type II
- CoaguChek XS Pro and Plus, Cobas H 232 Instruments (2017-12-18)January 29, 2018 · Medical devices · Medical devices · Type II
- Heat cure acrylic powder, HC and SC Monomer (2017-12-22)January 29, 2018 · Medical devices · Medical devices · Type III
- Cobas MPX (2017-12-21)January 29, 2018 · Medical devices · Medical devices · Type III
- Foot control (2017-12-22)January 29, 2018 · Medical devices · Medical devices · Type II
- COULTER EPICS Flow Cytometers, Cytomics FC500 Flow Cytometer, Cytomics FC 500 MPL (Flow Cytometer) and EPICS XL/MCL Analyzer (2018-01-08)January 16, 2018 · Medical devices · Medical devices · Type I
- Kenevo (2017-12-08)January 12, 2018 · Medical devices · Medical devices · Type II
- Axiom Artis - dFA, dBA, dTA, FC, dFC, FA Alpha, MP Diagnostic, BC, BA, TA, dTC, dBC, and dBC, dFC Magnetic Navigation; Artis - Zee Floor MN, Q and Q.Zen, Artis - Zee Biplane MN, Zeego Multi-Axis, Zee Floor, Zee Floor MN, Zee Ceiling, Zee Biplane (201...January 12, 2018 · Medical devices · Type II
- Haemophilus Test Medium (2017-12-01)January 12, 2018 · Medical devices · Medical devices · Type III
- Clip Gun System - Clip Gun (2017-12-18)January 12, 2018 · Medical devices · Medical devices · Type II
- Disposable Drill Kit (2017-12-21)January 12, 2018 · Medical devices · Medical devices · Type II
- XN CHECK BF (2017-12-06)January 12, 2018 · Medical devices · Medical devices · Type III
- Optima CT660 and Revolution EVO (2017-06-01)January 12, 2018 · Medical devices · Medical devices · Type III
- SPI VECTOdrill twist drill, long, single use, stainless steel (2017-12-21)January 12, 2018 · Medical devices · Medical devices · Type III
- ARCHITECT Hemoglobin A1c (2017-12-21)January 12, 2018 · Medical devices · Medical devices · Type III
- Vascuteks' various Gelweave, ePTFE, SEALPTFE, Thin Wall Fluoropassiv, Gelsoft ERS, Gelsoft Plus, Gelsoft Plus ERS and GelsealERT Vascular Prosthesis (2017-12-13)January 12, 2018 · Medical devices · Medical devices · Type III
- Equinox Advantage N2O/O2 Analgesic Gas Mixing and Delivery System (2017-12-21)January 12, 2018 · Medical devices · Medical devices · Type II
- i-STAT Kaolin ACT Cartridge (2017-12-21)January 12, 2018 · Medical devices · Medical devices · Type III
- iVIEW DAB, ultraView Universal DAB, ultraView SISH DNP, OptiView DAB IHC Detection Kit and OptiView Amplification Kit, CINtec PLUS Cytology Kit, Hematoxylin II (2017-12-27)January 12, 2018 · Medical devices · Medical devices · Type II
- ETEST Antimicrobial Susceptibility Testing - Teicoplanin (2017-12-14)January 12, 2018 · Medical devices · Medical devices · Type II
- CFPM300, CFPM301, CFPM400 and CFPM401 - Integrated Headrest, CFUR301, CFUR401 - Urology Table and CFLU401 Lithotripsy-Urology (2017-12-08)January 12, 2018 · Medical devices · Medical devices · Type II
- ImmunoCAP Allergen c6, Amoxicilloyl and c5, Ampicilloyl (2017-12-28)January 12, 2018 · Medical devices · Medical devices · Type III
- ADVIA Centaur System - B-Type Natriupretic Peptide (BNP), TSH3-ULTRA (TSH3-UL) Assay and ADVIA Centaur CP System - B-Type Natriupretic Peptide (BNP), TSH3-ULTRA (TSH3-UL) Assay (2017-12-21)January 12, 2018 · Medical devices · Medical devices · Type III
- SwishPlus Implant (2018-01-04)January 12, 2018 · Medical devices · Medical devices · Type II
- Dimension Vista - Drugs of Abuse Controls (2017-12-21)January 12, 2018 · Medical devices · Medical devices · Type III
- SIGMA HP PFJ Cemented Trochlear Implants (2017-12-22)January 12, 2018 · Medical devices · Medical devices · Type II
- HC and SC Monomer (2017-12-22)January 12, 2018 · Medical devices · Medical devices · Type III
- PneumoClear (2017-11-13)January 12, 2018 · Medical devices · Medical devices · Type III
- Arrow Internationals' various Central Venous Catheterization Kits/Sets, Central Venous Cather Kits/Sets, Pressure Injectable PICC Kits/Sets and Percutaneous Sheath Introducer Set (2017-12-22)January 11, 2018 · Medical devices · Medical devices · Type II
- Arrow International's various Central Venous Catheter Kits (2017-11-29)January 8, 2018 · Medical devices · Medical devices · Type II
- Pentacam Axl (2017-11-27)January 8, 2018 · Medical devices · Medical devices · Type II
- Sysmex XN-L Series (2017-12-01)January 8, 2018 · Medical devices · Medical devices · Type III
- CRYOcheck Factor II Deficient Plasma (2017-12-07)January 8, 2018 · Medical devices · Medical devices · Type III
- Precedence System - 6 and 16 Slice, Brightview Gamma - Camera Sy. W/ 3/8" Crystal & Detector Caudal Cephalic Tilt, Xct Imaging System - Tilt System and Syst, Brightview X With Crystal, 3/8" (Upgradeable Version) (2017-12-21)January 8, 2018 · Medical devices · Medical devices · Type II
- iChemVELOCITY Urine Chemistry Strips (2017-12-04)January 8, 2018 · Medical devices · Medical devices · Type II
- IPS CaseDesigner (2017-12-11)January 8, 2018 · Medical devices · Medical devices · Type II
- ClearSight Heart Reference Sensor (2017-12-11)January 8, 2018 · Medical devices · Medical devices · Type III
- 3-Way Latex Foley Catheter (2017-12-15)January 8, 2018 · Medical devices · Medical devices · Type II
- Non-Filtered Curlin IV Administration Sets with Spikes (2017-12-14)January 8, 2018 · Medical devices · Medical devices · Type II
- Grace Hysterectomy Pack and Ensemble Prothese De Genou (2016-03-16)January 8, 2018 · Medical devices · Medical devices · Type II
- Confidence and Confidence Plus Kit Spinal Cement System (2017-12-18)January 8, 2018 · Medical devices · Medical devices · Type II
- IGEA Fast - Multistandard System, Probe, Probe Support, Power Supply, Gel Pad, Orange Ring and Vaporizer (2017-12-14)January 8, 2018 · Medical devices · Medical devices · Type II
- Jackson-Pratt Drain (2017-12-06)January 8, 2018 · Medical devices · Medical devices · Type II
- Artisan - Automated Slide Stainer, Link and Link Pro (2017-12-21)January 8, 2018 · Medical devices · Medical devices · Type II
- ARCHITECT I System - DHEA-S Assay (2017-12-19)January 8, 2018 · Medical devices · Medical devices · Type II
- DERMABOND PRINEO Skin Closure System (2017-12-01)January 8, 2018 · Medical devices · Medical devices · Type II
- Tapered Screw-Vent Implant MTX Full (2017-12-06)January 8, 2018 · Medical devices · Medical devices · Type II
- Tapered Screw-Vent Implant Wide and MTX Full (2017-12-06)January 8, 2018 · Medical devices · Medical devices · Type II
- Signia Power Handle (2017-12-13)January 8, 2018 · Medical devices · Medical devices · Type II
- Re-Entry Malecot Nephrostomy Catheter (2017-12-13)January 8, 2018 · Medical devices · Medical devices · Type II
- Guider SoftTip XF (2017-12-13)January 8, 2018 · Medical devices · Medical devices · Type II
- LIFEPAK 20e DEFIBRILLATOR/MONITOR (2017-12-07)January 8, 2018 · Medical devices · Medical devices · Type II
- CellVision DM96, DM1200 and DM9600 (2017-12-07)January 8, 2018 · Medical devices · Medical devices · Type II
- Shigella Sonnei (Phases 1 and 2) Agglutinating Serum (2017-11-21)January 8, 2018 · Medical devices · Medical devices · Type II
- ORTHOPANTOMOGRAPH OP 3D (2017-12-05)January 8, 2018 · Medical devices · Medical devices · Type II
- LIPC (Lipase Colorimetric) for Cobas C701 Analyzer (2017-12-06)January 8, 2018 · Medical devices · Medical devices · Type III
- Siemens' various Immulite Systems (2017-12-18)January 8, 2018 · Medical devices · Medical devices · Type III
- ADIVA Chemistry System - Liquid Specific Protein Calibrators Including Series 1200, 1800 And 2400 (2017-12-08)January 8, 2018 · Medical devices · Medical devices · Type III
- Angiotouch Hand Controller Kit (2017-12-19)January 8, 2018 · Medical devices · Medical devices · Type II
- Band-Aid Brand First Aid Products Hurt-Free Tape (2017-12-19)January 8, 2018 · Medical devices · Medical devices · Type II
- Immulite System- IGF-1 (Insulin like Growth Hormone) - 1000 and 2000 Assay (2017-11-30)January 8, 2018 · Medical devices · Medical devices · Type III
- Kyphx Bone Filler Device (2017-12-08)January 8, 2018 · Medical devices · Medical devices · Type II