Health product recalls and alerts, 2020
905 notices, newest first. Each links to the official notice.
Drugs, vaccines and biologics
- GUM Paroex (2020-12-24)December 24, 2020 · Drugs · Product safety · Type I
- GUM Paroex (anti-gingivitis oral rinse) being recalled due to microbial contamination that could lead to respiratory and other infections in patientsDecember 24, 2020 · Drugs
- Authorization of Moderna COVID-19 Vaccine with English-only Vial and Carton LabelsDecember 23, 2020 · Biologic or vaccine · COVID - Product safety
- Anti-Microbe (2020-12-22)December 22, 2020 · Drugs · Product safety · Type II
- Bacitracin for Injection (50,000 IU per vial) and the Risk of Nephrotoxicity and Anaphylactic ReactionsDecember 21, 2020 · Drugs · Product safety
- Authorization of Bamlanivimab with English-only Labels for Use in Relation to the COVID-19 PandemicDecember 18, 2020 · Biologic or vaccine · COVID - Product safety
- Zerbaxa (2020-12-16)December 16, 2020 · Drugs · Product safety · Type I
- Health Canada warns Canadians not to buy COVID-19 vaccines sold online or from unauthorized sourcesDecember 16, 2020 · Health products · COVID
- Rhinaris Nasal Mist (2020-12-15)December 15, 2020 · Drugs · Product safety · Type II
- ELMIRON (pentosan polysulfate sodium) and the Risk of Pigmentary MaculopathyDecember 15, 2020 · Drugs · Product safety
- PMS-Pregabalin 50mg (2020-12-14)December 14, 2020 · Drugs · Product safety · Type II
- Pfizer-BioNTech COVID-19 vaccine: Health Canada recommendations for people with serious allergiesDecember 12, 2020 · Biologic or vaccine · COVID - Product safety
- Authorization of Pfizer-BioNTech COVID-19 Vaccine with English-only Carton and Vial LabelsDecember 12, 2020 · Biologic or vaccine · COVID - Product safety
- Methylene Blue Injection USP 10mg/mL (2020-12-11)December 11, 2020 · Drugs · Product safety · Type II
- Importation of US-labelled Dexrazoxane for Injection distributed by Mylan Pharmaceuticals ULC due to shortage of Canadian-labelled DexrazoxaneDecember 1, 2020 · Drugs · Product safety
- Pregabalin 50mg (2020-11-30)November 30, 2020 · Drugs · Product safety · Type II
- Rhinaris Nasal Spray (2020-11-19)November 19, 2020 · Drugs · Product safety · Type II
- Taro Pharmaceuticals Inc. Product Recall (2020-11-17)November 17, 2020 · Drugs · Product safety · Type II
- 30ml Reduced-Glutathione 200mg/ml (2020-11-13)November 13, 2020 · Drugs · Product safety · Type I
- Ramipril 5 mg (2020-11-09)November 9, 2020 · Drugs · Product safety · Type II
- Anzar Consultants Inc./Masters Tobacco Product Recall (2020-11-04)November 4, 2020 · Drugs · Product safety · Type II
- Unauthorized nicotine buccal pouches may pose serious health risksNovember 2, 2020 · Drugs
- Recalls of Regener-Eyes Ophthalmic Solution and Regener-Eyes Ophthalmic Solution LiteOctober 30, 2020 · Drugs
- Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) beyond 20 weeks of pregnancy and risk of kidney damage in unborn babies, leading to low amniotic fluidOctober 30, 2020 · Drugs
- Updates to safety labelling for benzodiazepines and benzodiazepine-like drugsOctober 30, 2020 · Drugs
- Codeine Phosphate Syrup (2020-10-29)October 29, 2020 · Drugs · Product safety · Type I
- Laboratoire Atlas Inc. is recalling one lot of "ATLAS - Codeine phosphate syrup 5 mg/mL" because some bottles contain isopropyl rubbing alcoholOctober 29, 2020 · Drugs
- Kretek International Canada Product Recall (2020-10-28)October 28, 2020 · Drugs · Product safety · Type II
- GUM Paroex (2020-10-28)October 28, 2020 · Drugs · Product safety · Type I
- LEO Pharma Inc. is withdrawing the drug Picato (Ingenol mebutate), used to treat skin lesions, due to the potential increased risk of skin cancerOctober 27, 2020 · Drugs
- PICATO (ingenol mebutate gel, 0.015% and 0.05%) - Product Withdrawal in Canada due to Potential Increased Risk of Skin CancerOctober 27, 2020 · Drugs · Product safety
- Leo Pharma Canada Inc. Product Recall (2020-10-26)October 26, 2020 · Drugs · Product safety · Type II
- Regener-Eyes Ophthalmic Solution (2020-10-26)October 26, 2020 · Drugs · Product safety · Type I
- Regener-Eyes Ophthalmic Solution Lite (2020-10-24)October 24, 2020 · Drugs · Product safety · Type I
- Regener-Eyes Ophthalmic Solution (2020-10-24)October 24, 2020 · Drugs · Product safety · Type I
- Regener-Eyes Ophthalmic Solution (2020-10-23)October 23, 2020 · Drugs · Product safety · Type I
- Benzocaine-Containing Products and the Risk of Methemoglobinemia in Children under Two Years of AgeOctober 22, 2020 · Drugs · Product safety
- ZYN Nicotine Pouches (2020-10-19)October 19, 2020 · Drugs · Product safety · Type II
- An unauthorized biologic eye drop, Regener-Eyes Ophthalmic Solution, recalled after Edmonton clinic found to be importing and selling itOctober 4, 2020 · Drugs
- FIBRISTAL (ulipristal acetate tablets, 5 mg) - Voluntary Withdrawal in Canada due to Risk of Drug-Induced Liver InjurySeptember 30, 2020 · Drugs · Product safety
- Allergan Inc. voluntarily withdraws its drug Fibristal, used to treat uterine fibroids, from the Canadian marketSeptember 30, 2020 · Drugs
- Peridex Oral Rinse (2020-09-28)September 28, 2020 · Drugs · Product safety · Type III
- Regener-Eyes Ophthalmic Solution (2020-09-28)September 28, 2020 · Drugs · Product safety · Type I
- Fibristal 5MG (2020-09-24)September 24, 2020 · Drugs · Product safety · Type II
- All strengths of MAR-Diltiazem CD, a drug used to treat angina and hypertension, have been recalled because of dosing concernsSeptember 24, 2020 · Drugs
- Marcan Pharmaceuticals Inc. Product Recall (2020-09-18)September 18, 2020 · Drugs · Product safety · Type I
- Unauthorized health products sold on Steroid Hub Canada website may pose serious health risksSeptember 18, 2020 · Drugs
- Importation of US Clinical Trial-Labelled Remdesivir for Injection Due to Shortage of Canadian-Labelled RemdesivirSeptember 15, 2020 · Drugs · COVID - Product safety
- Jardiance (2020-09-14)September 14, 2020 · Drugs · Product safety · Type III
- ESBRIET (pirfenidone) and the Risk of Drug-Induced Liver InjurySeptember 14, 2020 · Drugs · Product safety
- pms-Ranitidine 150mg (2020-08-28)August 28, 2020 · Drugs · Product safety · Type I
- Dexedrine Spansule SRC 10MG (2020-08-28)August 28, 2020 · Drugs · Product safety · Type II
- Ranitidine Injection USP (2020-08-27)August 27, 2020 · Drugs · Product safety · Type I
- Prescription Cough and Cold Products Containing Opioids and the Risk of Opioid Use Disorder in Children and Adolescents (< 18 years of age)August 24, 2020 · Drugs · Product safety
- Teva Canada Limited Product Recall (2020-08-21)August 21, 2020 · Drugs · Product safety · Type II
- Acyclovir Sodium Injection (2020-08-18)August 18, 2020 · Drugs · Product safety · Type I
- Mirage Antibacterial Wipes (2020-08-08)August 8, 2020 · Drugs · Product safety - COVID · Type II
- Extra Strength Diaper Rash Ointment (2020-08-03)August 3, 2020 · Drugs · Product safety · Type III
- Non-prescription pain relief products containing codeine are not recommended for use in people under 18 years of ageJuly 31, 2020 · Drugs
- Remdesivir authorized with conditions for the treatment of patients in Canada with severe COVID-19 symptomsJuly 28, 2020 · Drugs · COVID
- Teva-Triamterene/HCTZ (2020-07-24)July 24, 2020 · Drugs · Product safety · Type III
- Status of ranitidine drugs in CanadaJuly 23, 2020 · Drugs
- Taro Pharmaceuticals Inc. Product Recall (2020-07-20)July 20, 2020 · Drugs · Product safety · Type III
- Methadone Treatment of Opioid Dependence and Potential Risk of Lack of Effect when Switching between Different ProductsJuly 17, 2020 · Drugs · Product safety
- Three lots of antidiuretic DDAVP Spray recalled because of potential overdose riskJuly 16, 2020 · Drugs
- DDAVP Nasal Spray, 2.5 mL/5 mL (2020-07-14)July 14, 2020 · Drugs · Product safety · Type II
- Aldara P (2020-07-13)July 13, 2020 · Drugs · Product safety · Type II
- Dextrose 5% Injection (2020-07-11)July 11, 2020 · Drugs · Product safety · Type I
- SPF 30 SUNSCREEN LOTION (2020-07-09)July 9, 2020 · Drugs · Product safety · Type III
- Certain vials of fertility drug Cetrotide recalled because of potential contaminationJuly 4, 2020 · Drugs
- Cetrotide (2020-07-03)July 3, 2020 · Drugs · Product safety · Type I
- Information Update - Use of the drug Picato may increase the risk of skin cancerJuly 2, 2020 · Drugs
- Hoffman-La Roche Herceptin Product Recall (2020-06-27)June 27, 2020 · Drugs - Biologic or vaccine · Product safety · Type I
- NARDIL (phenelzine sulfate) ShortageJune 24, 2020 · Drugs · Product safety
- MabCampath (alemtuzumab) - Risk of Haemophagocytic Lymphohistiocytosis, Stroke (including ischaemic and haemorrhagic stroke), and GlomerulonephritisJune 22, 2020 · Drugs · Product safety
- Certain Metformin diabetes drugs recalled due to the presence or possible presence of NDMAJune 13, 2020 · Drugs
- APO-Metformin (2020-06-12)June 12, 2020 · Drugs · Product safety · Type I
- APO-Entecavir (2020-06-09)June 9, 2020 · Drugs · Product safety · Type III
- Teva-Carvedilol (2020-06-05)June 5, 2020 · Drugs · Product safety · Type II
- PMS-Sildenafil R (2020-06-02)June 2, 2020 · Drugs · Product safety · Type II
- Teva-Cotridin (2020-06-01)June 1, 2020 · Drugs · Product safety · Type III
- Health Canada advises Canadians to help support the continued supply of medicationsJune 1, 2020 · Drugs · COVID
- Importation of US-Labelled Rocuronium Bromide Injection distributed by Avir Pharma Inc. Due to Shortage of Canadian-labelled RocuroniumMay 25, 2020 · Drugs · Product safety
- Cisatracurium Omega Multi-Dose (Cisatracurium Besylate Injection): Temporary change of ferrule (metal seal) colour to maintain continued supply in CanadaMay 25, 2020 · Drugs · Product safety
- Importation of US-Labelled Rocuronium Bromide Injection Due to Shortage of Canadian-labelled RocuroniumMay 25, 2020 · Drugs · Product safety
- Splash Corporation Maxi-Peel Exfoliant product recall (2020-05-22)May 22, 2020 · Drugs · Product safety · Type II
- Duavive (2020-05-20)May 20, 2020 · Drugs · Product safety · Type II
- Importation of Spanish-Labelled Salbutamol Aldo-Union inhalers due to Shortage of Canadian-Labelled SalbutamolMay 19, 2020 · Drugs · Product safety
- Importation of Fresenius Propoven 2% due to Shortage of Canadian Labelled Propofol Injection 1% ProductsMay 19, 2020 · Drugs · Product safety
- Penicillin G Sodium for Injection (2020-05-16)May 16, 2020 · Drugs · Product safety · Type I
- Important Safety Information - Importation of Teva UK-labelled Salamol CFC-Free (Salbutamol Sulfate) Inhaler due to ShortageMay 13, 2020 · Drugs · Product safety
- Glucovision (Citrate) (2020-05-11)May 11, 2020 · Radiopharmaceuticals · Product safety · Type III
- Ratio-Cotridine (2020-05-08)May 8, 2020 · Drugs · Product safety · Type III
- Tepadina (2020-05-08)May 8, 2020 · Drugs · Product safety · Type I
- Importation of US-Labelled Ketamine Hydrochloride for Injection due to Potential Shortage of Canadian-labelled KetamineMay 6, 2020 · Drugs · Product safety
- Axid (nizatidine) drug recalled due to presence of NDMAMay 1, 2020 · Drugs
- Clinical trial looking at the potential use of convalescent plasma to treat COVID-19May 1, 2020 · Biologic or vaccine · COVID
- AXID (2020-04-29)April 29, 2020 · Drugs · Product safety · Type I
- Importation of US-Labelled Pancuronium Bromide Injection Due to Shortage of Neuromuscular Blocker ProductsApril 29, 2020 · Drugs · Product safety
- Importation of US-Labelled Rocuronium Bromide Injection Due to Shortage of Canadian-labelled RocuroniumApril 29, 2020 · Drugs · Product safety
- Importation of US-Labelled QUELICIN (succinylcholine chloride injection) due to Shortage of Canadian-labelled QUELICINApril 29, 2020 · Drugs · Product safety
- Importation of US-Labelled Vecuronium Bromide for Injection due to Shortage of Neuromuscular Blocker ProductsApril 29, 2020 · Drugs · Product safety
- Chloroquine and hydroxychloroquine can have serious side effects. These drugs should be used only under the supervision of a physician.April 25, 2020 · Drugs · Product safety - COVID
- Amended: Betaderm Ointment (2020-03-23)April 24, 2020 · Drugs · Product safety · Type III
- Acetylcysteine Injection (2020-04-23)April 23, 2020 · Drugs · Product safety · Type III
- Marvelon 21 (2020-04-21)April 21, 2020 · Drugs · Product safety · Type II
- Shortage of salbutamol inhalers in CanadaApril 17, 2020 · Drugs · COVID
- Clinical management support: Known interference between Hemlibra® (emicizumab injection) and lab assays used to diagnose coagulopathy / DIC caused by COVID-19 infectionApril 17, 2020 · Biologic or vaccine · Product safety
- Ultravate (2020-04-15)April 15, 2020 · Drugs · Product safety · Type II
- APO-Entecavir (2020-04-15)April 15, 2020 · Drugs · Product safety · Type III
- Health Canada is temporarily authorizing the use of technical-grade ethanol in hand sanitizer products: Always follow the label directions when using alcohol-based hand sanitizersApril 15, 2020 · Drugs · COVID
- Xerese (2020-04-07)April 7, 2020 · Drugs · Product safety · Type III
- Nitrogen NF 99% (2020-04-02)April 2, 2020 · Drugs · Product safety · Type III
- Homemade hand sanitizers may present health risksApril 2, 2020 · Drugs · COVID
- Methadone Treatment of Opioid Dependence and Potential Differences in Product EffectMarch 31, 2020 · Drugs · Product safety
- Certain Lots of Taro-Zoledronic acid injection drug, used for osteoporosis and Paget's disease, recalled due to potential presence of particulate matterMarch 31, 2020 · Drugs
- Taro-Zoledronic Acid (2020-03-30)March 30, 2020 · Drugs · Product safety · Type I
- Stockpiling drugs can lead to local shortages: Canadians urged not to buy more medication than usual during the COVID-19 pandemicMarch 30, 2020 · Drugs · COVID
- Betaderm Ointment (2020-03-23)March 23, 2020 · Drugs · Product safety · Type III
- No scientific evidence that ibuprofen worsens COVID-19 symptomsMarch 20, 2020 · Drugs · Product safety - COVID
- Sterimax Tetrabenazine (2020-03-18)March 18, 2020 · Drugs · Product safety · Type III
- Fludeoxyglucose (18F) Injection (2020-03-16)March 16, 2020 · Drugs · Product safety · Type II
- Update on the rifampin drug shortageMarch 15, 2020 · Drugs
- Indefense30 (2020-03-13)March 13, 2020 · Drugs · Product safety · Type III
- Jamp-Metformin Product Recall (2020-03-10)March 10, 2020 · Drugs · Product safety · Type I
- Unauthorized skin lightening products seized from Blue Sky Supermarket: products may pose serious health risksMarch 10, 2020 · Drugs
- Brigham Enterprises Inc. Product Recall (2020-03-04)March 4, 2020 · Drugs · Product safety · Type II
- OMEP (2020-02-28)February 28, 2020 · Drugs · Product safety · Type II
- Pro Doc Zolmitriptan ODT (2020-02-26)February 26, 2020 · Drugs · Product safety · Type II
- PMS-Zolmitriptan ODT (2020-02-26)February 26, 2020 · Drugs · Product safety · Type II
- Ranbaxy Metformin Product Recall (2020-02-26)February 26, 2020 · Drugs · Product safety · Type I
- LC-MV 10 (2020-02-25)February 25, 2020 · Veterinary drugs · Product safety · Type III
- MicroSintesis YGIA Product Recall (2020-02-25)February 25, 2020 · Veterinary drugs · Product safety · Type III
- Zoetis Canada Clavamox product recall (2020-02-21)February 21, 2020 · Veterinary drugs · Product safety · Type II
- Health Canada suspends licence for Performance Plus capsules: Product may pose serious health risksFebruary 11, 2020 · Drugs
- Naturalyte H-320 (2020-02-10)February 10, 2020 · Drugs · Product safety · Type III
- ACT Methylphenidate ER (2020-02-07)February 7, 2020 · Drugs · Product safety · Type II
- APO-Metformin (2020-02-04)February 4, 2020 · Drugs · Product safety · Type I
- Teva-Ramipril (2020-01-31)January 31, 2020 · Drugs · Product safety · Type III
- Heparin Sodium and 0.9% Sodium Chloride Injection (2020-01-31)January 31, 2020 · Drugs · Product safety · Type III
- Taro-Carbamazepine (2020-01-29)January 29, 2020 · Drugs · Product safety · Type II
- Bovimectin (2020-01-21)January 21, 2020 · Veterinary drugs · Product safety · Type III
- Ivermectin Liquid (2020-01-20)January 20, 2020 · Veterinary drugs · Product safety · Type III
- Pharmascience Inc. recalls one lot of prescription antifungal drug PMS-Nystatin Oral Suspension: Product may pose a choking riskJanuary 17, 2020 · Drugs
- Hizentra (2020-01-16)January 16, 2020 · Drugs - Biologic or vaccine · Product safety · Type II
- Invokamet (2020-01-15)January 15, 2020 · Drugs · Product safety · Type III
- PMS-Nystatin Suspension (2020-01-13)January 13, 2020 · Drugs · Product safety · Type II
- Docetaxel Injection (2020-01-06)January 6, 2020 · Drugs · Product safety · Type II
- Health Canada seized two unauthorized ZO Medical skin-whitening creams from Toronto Dermatology Centre in North York, Ontario, because they may pose serious health risksJanuary 3, 2020 · Drugs
Other health products
- Get ready for this summer’s heat with expert tips!June 22, 2020 · Other · Product safety
Natural health products
- Unconditional Love Canada, Inc. Product Recall (2020-12-11)December 11, 2020 · Natural health products · Product safety - COVID · Type II
- Silver Sanitizer (2020-12-09)December 9, 2020 · Natural health products · Product safety · Type II
- HeyPur (2020-11-30)November 30, 2020 · Natural health products · Product safety - COVID · Type II
- Unauthorized products may pose serious health risks (November 25, 2020)November 25, 2020 · Drugs - Natural health products
- Xero Germs (2020-11-23)November 23, 2020 · Natural health products · Product safety - COVID · Type II
- The 101 Coast Distillery Hand + Surface Sanitizer (2020-11-12)November 12, 2020 · Natural health products · Product safety - COVID · Type II
- Concept Manufacturing Ltd - Ethanol Sanitizer 75% (2020-11-12)November 12, 2020 · Natural health products · Product safety - COVID · Type II
- Siding 14 Brewing Company-Ethanol Sanitizer 80% (2020-11-05)November 5, 2020 · Natural health products · Product safety - COVID · Type II
- Bio Life Hand Sanitizer (2020-11-03)November 3, 2020 · Natural health products · Product safety - COVID · Type II
- Testing confirms Bio Life hand sanitizer poses health risks; products recalled across CanadaOctober 28, 2020 · Natural health products · COVID
- Snake Lake Brewing Company Ethanol Sanitizer 80% (2020-10-27)October 27, 2020 · Natural health products · Product safety - COVID · Type II
- D-for-All (2020-10-26)October 26, 2020 · Natural health products · Product safety · Type II
- Daily Shield Hand Sanitizer (2020-10-23)October 23, 2020 · Natural health products · COVID · Type II
- Unauthorized products may pose serious health risks (October 21, 2020)October 21, 2020 · Drugs - Natural health products
- L'il Critters Gummy Vites Complete Multivitamins (2020-10-20)October 20, 2020 · Natural health products · Product safety · Type III
- Benzocaine products should not be used in children under two years of ageOctober 15, 2020 · Natural health products
- PurGerme (2020-10-10)October 10, 2020 · Natural health products · Product safety - COVID · Type II
- Birds & Bees Distillery 70% Ethyl Alcohol (2020-10-07)October 7, 2020 · Natural health products · Product safety - COVID · Type II
- Pure Essentials Hand Spray (2020-10-06)October 6, 2020 · Natural health products · Product safety - COVID · Type II
- Prairie Potions Purify Hand Sanitizer & Antibacterial Spray (2020-10-06)October 6, 2020 · Natural health products · Product safety - COVID · Type II
- Nomad Hand Sanitizer (2020-10-01)October 1, 2020 · Natural health products · Product safety - COVID · Type II
- Recall of counterfeit Zytec Germ Buster Hand SanitizerOctober 1, 2020 · Natural health products · COVID
- Last Best Brewing & Distilling Hand Sanitizer (2020-09-30)September 30, 2020 · Natural health products · Product safety - COVID · Type II
- Sanix Gel d'alcool pour les mains avec émollients (2020-09-29)September 29, 2020 · Natural health products · Product safety - COVID · Type II
- Helping Hands Ethanol Sanitizer 72% (2020-09-23)September 23, 2020 · Natural health products · Product safety · Type II
- Counterfeit: Zytec Germ Buster (2020-09-18)September 18, 2020 · Natural health products · Product safety · Type II
- Unauthorized products may pose serious health risks (September 16, 2020: Part 2)September 16, 2020 · Drugs - Natural health products
- Unauthorized products may pose serious health risks (September 16, 2020: Part 1)September 16, 2020 · Drugs - Natural health products
- Keep Calm(2020-09-11)September 11, 2020 · Natural health products · COVID · Type II
- Alcohol Hand Rub (2020-09-10)September 10, 2020 · Natural health products · Product safety - COVID · Type II
- Bath Springs Hand Sanitizer (2020-09-04)September 4, 2020 · Natural health products · Product safety - COVID · Type II
- Hand Sanitizers and Children's Safety: What you need to knowSeptember 4, 2020 · Natural health products · COVID
- Clean Freak (2020-08-26)August 26, 2020 · Natural health products · Product safety - COVID · Type II
- Noteworthy Handrub (2020-08-26)August 26, 2020 · Natural health products · Product safety - COVID · Type II
- Blindman Brewing Hand Sanitizer (2020-08-26)August 26, 2020 · Natural health products · Product safety - COVID · Type II
- HydraPure Gel (2020-08-19)August 19, 2020 · Natural health products · Product safety - COVID · Type II
- Désinfectant pour les mains à base d'éthanol 70% (2020-08-19)August 19, 2020 · Natural health products · Product safety - COVID · Type II
- Holistic Living 70% Alcohol Antiseptic Disinfectant (2020-08-18)August 18, 2020 · Natural health products · Product safety - COVID · Type II
- Gal Hand Sanitizer (2020-08-14)August 14, 2020 · Natural health products · Product safety - COVID · Type II
- Solution Hydro-Alcoolique Pour Les Mains (2020-08-13)August 13, 2020 · Natural health products · Product safety - COVID · Type II
- 204 Hand Sanitizer (2020-08-04)August 4, 2020 · Natural health products · Product safety - COVID · Type II
- Happy Natural Products - Ethanol Sanitizer 80% (2020-07-31)July 31, 2020 · Natural health products · Product safety - COVID · Type III
- Clean & Green Hand Sanitizer Gel (2020-07-23)July 23, 2020 · Natural health products · Product safety - COVID · Type II
- Dermogen (2020-07-22)July 22, 2020 · Natural health products · COVID · Type II
- Sanatouch (2020-07-22)July 22, 2020 · Natural health products · Product safety - COVID · Type II
- Upstreet Craft Brewing Hand Sanitizer Product Recall (2020-07-20)July 20, 2020 · Natural health products · Product safety - COVID · Type II
- Hand Sanitizer (2020-07-17)July 17, 2020 · Natural health products · Product safety - COVID · Type II
- Mineral Origin Inc. Hand Sanitizer Product Recall (2020-07-15)July 15, 2020 · Natural health products · Product safety - COVID · Type II
- Opti-Max Opti-Pure (2020-07-15)July 15, 2020 · Natural health products · Product safety - COVID · Type II
- Progel Plus (2020-07-14)July 14, 2020 · Natural health products · Product safety - COVID · Type II
- Airome Wintergreen Essential Oil (2020-07-13)July 13, 2020 · Natural health products · Product safety · Type III
- Septeeze (2020-07-13)July 13, 2020 · Natural health products · Product safety - COVID · Type II
- Gentle Hand Sanitizer with Aloe (2020-07-10)July 10, 2020 · Natural health products · Product safety - COVID · Type II
- BioVectra Hand Sanitizer Product Recall (2020-07-10)July 10, 2020 · Natural health products · Product safety - COVID · Type II
- MB Hand Sanitizer (2020-07-10)July 10, 2020 · Natural health products · Product safety - COVID · Type II
- Solutions Enviro-Formula Hand Sanitizer Product Recall (2020-07-10)July 10, 2020 · Natural health products · Product safety - COVID · Type II
- ARCHIVED - Recall of certain hand sanitizers that may pose health risksJuly 10, 2020 · Natural health products
- Manogel (2020-07-09)July 9, 2020 · Natural health products · Product safety - COVID · Type II
- Hand Sanitizer Alcohol Gel - Mano-San (2020-07-09)July 9, 2020 · Natural health products · Product safety - COVID · Type II
- Assainisseur À Base D'Éthanol 70% (2020-07-07)July 7, 2020 · Natural health products · COVID · Type II
- Germ Eliminator (2020-07-07)July 7, 2020 · Natural health products · COVID · Type II
- Agape (2020-07-06)July 6, 2020 · Natural health products · Product safety - COVID · Type II
- Adclean Technical (2020-07-06)July 6, 2020 · Natural health products · Product safety - COVID · Type II
- Purus (2020-07-03)July 3, 2020 · Natural health products · Product safety - COVID · Type II
- Archived - Recall of certain hand sanitizers that may pose health risksJuly 3, 2020 · Natural health products · COVID - Product safety
- Vima-San Hand Sanitizer (2020-07-02)July 2, 2020 · Natural health products · COVID · Type II
- eSafe (2020-07-01)July 1, 2020 · Natural health products · COVID · Type II
- Defend Gel Hand Sanitizer (2020-06-30)June 30, 2020 · Natural health products · Product safety - COVID · Type II
- Manogel (2020-06-30)June 30, 2020 · Natural health products · Product safety - COVID · Type II
- Sanify Hand Sanitizer (2020-06-30)June 30, 2020 · Natural health products · Product safety - COVID · Type II
- Ascencia Hand Sanitizer (2020-06-30)June 30, 2020 · Natural health products · Product safety - COVID · Type II
- Facility Plus Complete Facility Services-Hand Sanitizer 70% Alcohol (2020-06-29)June 29, 2020 · Natural health products · Product safety - COVID · Type II
- Sanitagel (2020-06-29)June 29, 2020 · Natural health products · COVID · Type II
- Germs Be Gone Hand Sanitizer Gel (2020-06-25)June 25, 2020 · Natural health products · Product safety - COVID · Type III
- Healthcare Plus Sanitizing Hand Gel (2020-06-25)June 25, 2020 · Natural health products · COVID · Type II
- Biogel (2020-06-25)June 25, 2020 · Natural health products · COVID · Type II
- Crown Chemical Hand Sanitizer Product Recall (2020-06-19)June 19, 2020 · Natural health products · COVID · Type II
- Mega-Biogel (2020-06-19)June 19, 2020 · Natural health products · COVID · Type II
- Protectenol (2020-06-18)June 18, 2020 · Natural health products · Product safety - COVID · Type II
- Visibly Clean Hand Sanitizer (2020-06-18)June 18, 2020 · Natural health products · COVID · Type II
- Avery Essentials Hand Sanitizer Product Recall (2020-06-17)June 17, 2020 · Natural health products · Product safety - COVID · Type II
- Tekare Instant Hand Cleanser Gel (2020-06-16)June 16, 2020 · Natural health products · COVID · Type II
- GermZero Hand Sanitizer Gel (2020-06-16)June 16, 2020 · Natural health products · COVID · Type II
- Amended: Gigi's Goodbye Germs (2020-06-12)June 12, 2020 · Natural health products · Product safety - COVID · Type II
- Gel 700 Hand Sanitizer (2020-06-12)June 12, 2020 · Natural health products · COVID · Type II
- Isogel (2020-06-10)June 10, 2020 · Natural health products · COVID · Type II
- X-Pure Vert-2-Go (2020-06-10)June 10, 2020 · Natural health products · COVID · Type II
- Risk of poisoning from hand sanitizers sold in beverage containersJune 10, 2020 · Drugs - Natural health products · COVID
- Annex/Raft Hand Sanitizer (2020-06-08)June 8, 2020 · Natural health products · Product safety - COVID · Type II
- Aktif Antiseptique instantané pour les mains (2020-06-08)June 8, 2020 · Natural health products · COVID · Type II
- Dash Vapes Hand Sanitizer (2020-06-08)June 8, 2020 · Natural health products · COVID · Type II
- Protectenol (2020-06-05)June 5, 2020 · Natural health products · COVID · Type II
- Smart Care (2020-06-04)June 4, 2020 · Natural health products · Product safety - COVID · Type II
- Gel 700 Hand Sanitizer (2020-06-04)June 4, 2020 · Natural health products · Product safety - COVID · Type II
- Sanilabs Hand Sanitizer 70% Ethanol (2020-06-04)June 4, 2020 · Natural health products · Product safety - COVID · Type II
- Walker Emulsions Hand Sanitizer Product Recall (2020-06-03)June 3, 2020 · Natural health products · COVID · Type II
- Med Clean Hand Sanitizer Gel (2020-06-02)June 2, 2020 · Natural health products · Product safety - COVID · Type II
- Hand Sanitizer (2020-06-01)June 1, 2020 · Natural health products · Product safety - COVID · Type II
- Eltraderm Hand Sanitizer 70% Ethyl Alcohol (2020-06-01)June 1, 2020 · Natural health products · Product safety - COVID · Type II
- Consumers advised to stop using Akwaton International Multipurpose WipesMay 27, 2020 · Natural health products · COVID
- Some units of Triton Hand Sanitizer containing technical-grade ethanol sold in Canada without the necessary risk informationMay 27, 2020 · Natural health products · COVID - Product safety
- Riversol Lightweight Broad Spectrum Sunscreen Spf 30 (2020-05-01)May 1, 2020 · Natural health products · Product safety · Type II
- MCal Solution (2020-03-31)March 31, 2020 · Natural health products · Product safety · Type III
- Expedited access to disinfectants, hand sanitizers and personal protective equipment to help limit the spread of COVID-19, as well as swabs for testingMarch 31, 2020 · Natural health products - Medical devices · COVID
- Health products that make false or misleading claims to prevent, treat or cure COVID-19 may put your health at riskMarch 27, 2020 · Natural health products - Medical devices · COVID
- Unauthorized skin lightening product seized from Danforth Variety & Fruit Market: Product may pose serious health risksMarch 19, 2020 · Natural health products
- Unauthorized products may pose serious health risks (February 10, 2020 to March 13, 2020)March 13, 2020 · Drugs - Natural health products
- Amended: API Drops Alcohol Free (2020-02-20)February 20, 2020 · Natural health products · Product safety · Type II
- API Drops Alcohol Free (2020-02-20)February 20, 2020 · Natural health products · Product safety · Type III
- Ultra 03 (2020-02-14)February 14, 2020 · Natural health products · Product safety · Type II
- Ecotrend U.T.Vibrance Product Recall (2020-02-11)February 11, 2020 · Natural health products · Product safety · Type II
- Candi-Caine (2020-02-05)February 5, 2020 · Natural health products · Product safety · Type III
- Unauthorized skin lightening health products may pose serious health risksFebruary 5, 2020 · Drugs - Natural health products
- Ironkids Omega-3 Gummies (2020-01-24)January 24, 2020 · Natural health products · Product safety · Type III
- Unauthorized products may pose serious health risks (December 9, 2019 to January, 17 2020)January 17, 2020 · Drugs - Natural health products
Medical devices
- FebriDx (2020-12-21)December 31, 2020 · Medical devices · COVID - Medical devices · Type II
- QUADROX-I PEDIATRIC OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR (2020-12-21)December 31, 2020 · Medical devices · Medical devices · Type II
- VERSABOND AB 40 GRAMS FORMULATION 2 (2020-12-18)December 31, 2020 · Medical devices · Medical devices · Type II
- Cobas (2020-12-16)December 31, 2020 · Medical devices · Medical devices · Type II
- API PHARMA COVID-RAPID ANTIGEN TEST (2020-12-18)December 31, 2020 · Medical devices · COVID - Medical devices · Type II
- Carelink (2020-12-11)December 31, 2020 · Medical devices · Medical devices · Type II
- CAT-880B Catheterization (2020-12-14)December 31, 2020 · Medical devices · Medical devices · Type II
- NEUROSIGN 100 NERVE MONITOR (2020-12-07)December 31, 2020 · Medical devices · Medical devices · Type II
- I3 BioMedical TAS-150/155 Surgical Mask (2020-11-27)December 31, 2020 · Medical devices · COVID - Medical devices · Type II
- MagNA Pure 96 system (2020-06-23)December 31, 2020 · Medical devices · Medical devices · Type II
- POLYAXIAL SCREW (2020-12-22)December 30, 2020 · Medical devices · Medical devices · Type I
- Penumbra JET 7 Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing (2020-12-15)December 30, 2020 · Medical devices · Medical devices · Type I
- KN95 Face Mask (2020-12-09)December 24, 2020 · Medical devices · COVID - Medical devices · Type II
- MED-RX ANESTHESIA KITS (2020-12-14)December 24, 2020 · Medical devices · Medical devices · Type II
- NM (2020-12-10)December 24, 2020 · Medical devices · Medical devices · Type II
- ARES CATHETER (2020-12-08)December 24, 2020 · Medical devices · Medical devices · Type II
- HEARTWARE VENTRICULAR ASSIST SYSTEM - HVAD IMPLANT KIT (2020-12-08)December 24, 2020 · Medical devices · Medical devices · Type II
- AQT90 FLEX Analyzers (2020-12-01)December 24, 2020 · Medical devices · Medical devices · Type II
- FREEO2 AUTOMATED OXYGEN THERAPY DEVICE (2020-12-10)December 24, 2020 · Medical devices · Medical devices · Type II
- IOLMASTER700 (2020-12-07)December 24, 2020 · Medical devices · Medical devices · Type II
- ATELLICA (2020-12-08)December 24, 2020 · Medical devices · Medical devices · Type II
- UNI-COT (2020-12-15)December 24, 2020 · Medical devices · Medical devices · Type II
- ARTIS (2020-12-03)December 24, 2020 · Medical devices · Medical devices · Type II
- TA AUTOSUTURE VASCULAR STAPLER WITH DST SERIES TECHNOLOGY (2020-11-26)December 24, 2020 · Medical devices · Medical devices · Type II
- FLEXOR TOUHY-BORST SIDE-ARM INTRODUCER (SHUTTLE SEECT) & FLEXOR CHECK-FLO INTRODUCER (2020-11-25)December 24, 2020 · Medical devices · Medical devices · Type II
- REUSABLE MENSTRUAL CUP (2020-11-30)December 24, 2020 · Medical devices · Medical devices · Type II
- Maestro 4000 Cardiac Ablation System (2020-01-13)December 24, 2020 · Medical devices · Medical devices · Type II
- FACE MASK DISPOSABLE 3-PLY (2020-05-03)December 22, 2020 · Medical devices · COVID - Medical devices · Type II
- Regional Block Needles 22G x 1.50in (2020-12-10)December 22, 2020 · Medical devices · Medical devices · Type I
- Personal protective equipment sold by Maskopia (formerly Medkem Canada Inc.) may pose serious health risksDecember 22, 2020 · Medical devices · COVID - Medical devices
- Sysmex Automated Blood Coagulation Analyzers (2020-09-10)December 18, 2020 · Medical devices · Medical devices · Type II
- Oxford Partial Knee System Fixed Lateral Tibial Construct, Right-Cemented, E3 (2020-12-02)December 18, 2020 · Medical devices · Medical devices · Type II
- Cobas z 480 (2020-12-08)December 18, 2020 · Medical devices · Medical devices · Type II
- Non-Medical Foldable KN95 - Non-Sterile KN95 (2020-12-09)December 18, 2020 · Medical devices · COVID - Medical devices · Type II
- EMBLEM S-ICD PULSE GENERATOR & EMBLEM MRI S-ICD PG (2020-12-03)December 18, 2020 · Medical devices · Medical devices · Type II
- EMBLEM S-ICD SUBCUTANEOUS ELECTRODE (2020-12-03)December 18, 2020 · Medical devices · Medical devices · Type II
- EMBLEM S-ICD PULSE GENERATOR & EMBLEM MRI S-ICD PG (2020-12-03)December 18, 2020 · Medical devices · Medical devices · Type II
- Biomeme Go Mobile Smartphone Application (2020-10-26)December 18, 2020 · Medical devices · Medical devices · Type II
- ELONGATED FACE MASKS (2020-12-03)December 18, 2020 · Medical devices · Medical devices · Type II
- Multiple Sterile Zimmer Biomet Products (2020-12-02)December 18, 2020 · Medical devices · Medical devices · Type II
- Phadia System - ELIA DSDNA (2020-12-14)December 14, 2020 · Medical devices
- KN95 MASKS (2020-11-24)December 11, 2020 · Medical devices · COVID - Medical devices · Type II
- Spectrum IQ Infusion System with Dose IQ Safety Software (2020-11-26)December 11, 2020 · Medical devices · Medical devices · Type II
- SIGMA SPECTRUM Infusion System (V8 Platform) (2020-11-26)December 11, 2020 · Medical devices · Medical devices · Type II
- HysteroLux Fluid Management System (2020-11-23)December 11, 2020 · Medical devices · Medical devices · Type II
- VITROS® Automation Solutions configured with Thermo Scientific Aliquoter & Labeller Module (2020-11-23)December 11, 2020 · Medical devices · Medical devices · Type II
- RESPIRONICS V680 VENTILATOR (2020-11-23)December 11, 2020 · Medical devices · Medical devices · Type II
- Baxter Dialysis Machines (2020-11-17)December 11, 2020 · Medical devices · Medical devices · Type II
- Baxter Dialysis Machines (2020-11-17)December 11, 2020 · Medical devices · Medical devices · Type II
- Various LactoSorb System Implants (2020-10-30)December 11, 2020 · Medical devices · Medical devices · Type II
- Prismaflex Control Unit (2020-02-13)December 11, 2020 · Medical devices · Medical devices · Type II
- IceFORCE™, IcePearl™, IceRod™, IceSphere™, IceSeed™, IceEDGE™ Cryoablation Needles and Prostate Cryoablation Kits (2020-11-18)December 4, 2020 · Medical devices · Medical devices · Type II
- Clearlink Non-DEHP IV Infusion Sets (2020-11-23)December 4, 2020 · Medical devices · Medical devices · Type II
- Spinal Rod Cutter (2020-11-25)December 4, 2020 · Medical devices · Medical devices · Type II
- PrecisionGlide Needle, 30G x 1/2" (2020-11-19)December 4, 2020 · Medical devices · Medical devices · Type II
- TRIOFORCE BLUE NITRILE DISPOSABLE EXAM GLOVES (2020-11-23)December 4, 2020 · Medical devices · Medical devices · Type II
- YUKON ANTI TORQUE ALIGNMENT TUBE (2020-10-28)December 4, 2020 · Medical devices · Medical devices · Type II
- EASYCLIP AGRAFE BIPODE MONOCORTICALE & BICORTICALE SUPERELASTIQUE (2020-09-23)December 4, 2020 · Medical devices · Medical devices · Type II
- INFINITY ACL TIBIAL ELBOW AND TIP GUIDES (2020-11-10)November 27, 2020 · Medical devices · Medical devices · Type II
- ALTRIX PRECISION TEMPERATURE MANAGEMENT SYSTEM (2020-11-12)November 27, 2020 · Medical devices · Medical devices · Type II
- SENTINEL V10 CARDIOLOGY INFORMATION MANAGEMENT SYSTEM & SENTINEL V11 (2020-11-17)November 27, 2020 · Medical devices · Medical devices · Type II
- ELI 380 ELECTORCARDIOGRAPH (2020-11-13)November 27, 2020 · Medical devices · Medical devices · Type II
- PROCEDURAL GOWN - LEVEL 2 AATCC42/127 (2020-11-05)November 27, 2020 · Medical devices · Medical devices · Type II
- Somatom Definition Edge System CT System & Somatom Drive (2020-11-13)November 27, 2020 · Medical devices · Medical devices · Type II
- Custom Procedure Packs (2020-11-13)November 27, 2020 · Medical devices · Medical devices · Type II
- KN95 Respirators (2020-10-16)November 27, 2020 · Medical devices · COVID - Medical devices · Type II
- Technologist Choice Earloop Masks, DIS-050B (2020-11-10)November 27, 2020 · Medical devices · Medical devices · Type II
- LAERDAL COMPACT SUCTION UNIT 4 (LCSU 4) (2020-10-20)November 27, 2020 · Medical devices · Medical devices · Type II
- K-ACT Kaolin ACT Tubes (2020-11-09)November 27, 2020 · Medical devices · Medical devices · Type II
- Paragon CRT Dual Axis Contact Lenses (2020-10-15)November 27, 2020 · Medical devices · Medical devices · Type II
- CareLink Software Suite (2020-10-28)November 27, 2020 · Medical devices · Medical devices · Type II
- COBAS INFINITY CENTRAL LAB (2019-05-30)November 27, 2020 · Medical devices · Medical devices · Type II
- Medical Infrared Thermometer TY-8551 (2020-07-31)November 27, 2020 · Medical devices · Medical devices · Type II
- X8 Infrared Thermometer (2020-07-31)November 27, 2020 · Medical devices · Medical devices · Type II
- NANOCLAVE EXT SET (2020-06-29)November 27, 2020 · Medical devices · Medical devices · Type II
- Mayfield A2000 Skull Clamp Instruction Manual (2020-11-11)November 20, 2020 · Medical devices · Medical devices · Type II
- HLS Set Advanced 5.0/7.0 with BIOLINE Coating (2020-11-10)November 20, 2020 · Medical devices · Medical devices · Type II
- MINICAP EXTENDED LIFE PD TRANSFER SET W/TWIST CLAMP (2020-11-06)November 20, 2020 · Medical devices · Medical devices · Type II
- Hemoconcentrator Set (2020-11-05)November 20, 2020 · Medical devices · Medical devices · Type II
- DIAGNOSTIC ULTRASOUND SYSTEMS (2020-11-03)November 20, 2020 · Medical devices · Medical devices · Type II
- NEEVA BABY FETAL DOPPLER (2020-08-02)November 20, 2020 · Medical devices · Medical devices · Type II
- ABL800 FLEX Analyzer (2020-05-07)November 20, 2020 · Medical devices · Medical devices · Type II
- Ultraviolet (UV) lights and wands falsely claiming to disinfect against COVID-19November 18, 2020 · Medical devices · COVID
- Bellavista 1000 (NEO) & 1000E Ventilators (2019-11-22)November 13, 2020 · Medical devices · Medical devices · Type II
- ARCHITECT I SYSTEM - EBV VCA IgM Calibrator (2020-11-03)November 13, 2020 · Medical devices · Medical devices · Type II
- Syngo.via (2020-10-30)November 13, 2020 · Medical devices · Medical devices · Type II
- MAC VU360 (2020-10-27)November 13, 2020 · Medical devices · Medical devices · Type II
- Atellica IM 1300 & 1600 Analyzer (2020-10-29)November 13, 2020 · Medical devices · Medical devices · Type II
- TRACOE Twist Plus Tracheostomy Tubes (2020-10-28)November 13, 2020 · Medical devices · Medical devices · Type II
- COREVALVE EVOLUT R & COREVALVE EVOLUT PRO (2020-10-23)November 13, 2020 · Medical devices · Medical devices · Type II
- SAFETY-INXS DISPOSABLE Nitrile Gloves (2020-10-30)November 13, 2020 · Medical devices · Medical devices · Type II
- SYNGO DYNAMICS (2020-10-27)November 13, 2020 · Medical devices · Medical devices · Type II
- Invacare Perfecto2 V Oxygen Concentrator (2020-10-05)November 13, 2020 · Medical devices · Medical devices · Type II
- Unlicensed soft-shelled hyperbaric chambers may pose serious health risksNovember 6, 2020 · Medical devices · Unauthorized product
- Puritan Bennett 980 Series Ventilator (2020-10-21)November 6, 2020 · Medical devices · Medical devices · Type II
- Nitrile Examination Gloves (2020-09-15)November 6, 2020 · Medical devices · COVID - Medical devices · Type II
- PERFORATOR BIT - CRANIUM (2020-10-20)November 6, 2020 · Medical devices · Medical devices · Type II
- Alpen Clinic 100 Carbide & Alpen SteriX (2020-10-16)November 6, 2020 · Medical devices · Medical devices · Type II
- Synapse PACS versions 5.x (2020-10-05)November 6, 2020 · Medical devices · Medical devices · Type II
- BioHorizons Canada Medical Devices (2020-09-30)October 30, 2020 · Medical devices · Medical devices · Type II
- COMPANION 1000 PORTABLE (2020-10-16)October 30, 2020 · Medical devices · Medical devices · Type II
- Klebsiella Pneumoniae Derived from NCTC 13439 (2020-10-19)October 30, 2020 · Medical devices · Medical devices · Type II
- BD MULTI-CHECK CD4 LOW CONTROL (2020-10-13)October 30, 2020 · Medical devices · Medical devices · Type II
- Makrite Respirators (2020-08-04)October 30, 2020 · Medical devices · COVID - Medical devices · Type II
- Loye Infrared Thermometer (2020-09-30)October 30, 2020 · Medical devices · Medical devices · Type II
- 3M? Red Dot? Monitoring Electrode with Foam Tape (2020-10-13)October 30, 2020 · Medical devices · Medical devices · Type II
- IMPLANTOLOGY SET (2020-10-06)October 30, 2020 · Medical devices · Medical devices · Type II
- N95 Respirator Masks with Ear Loop (2020-09-29)October 30, 2020 · Medical devices · COVID - Medical devices · Type II
- Kangaroo Enteral Feeding Spike Sets (2020-09-23)October 23, 2020 · Medical devices · Medical devices · Type II
- TAQPATH COVID-19 RT-PCR KIT & APPLIED BIOSYSTEMS COVID-19 INTERPRETIVE SOFTWARE (2020-10-09)October 23, 2020 · Medical devices · COVID - Medical devices · Type II
- NEURO|MATE STEREOTACTIC SYSTEM (2020-10-12)October 23, 2020 · Medical devices · Medical devices · Type II
- Heater-Cooler Unit HCU 40 (2020-10-08)October 23, 2020 · Medical devices · Medical devices · Type II
- HemoSphere Oximetry Cable (2020-10-08)October 23, 2020 · Medical devices · Medical devices · Type II
- Aisys CS2 Anesthesia Machine Main Unit (2020-09-29)October 23, 2020 · Medical devices · Medical devices · Type II
- Monoject Standard Hypodermic Needles (2020-09-28)October 23, 2020 · Medical devices · Medical devices · Type II
- IACS MONITORING SOLUTION WITH C500/C700 & INFINITY M540 (2020-10-08)October 20, 2020 · Medical devices · Medical devices · Type I
- Fabian HFO and Fabian +nCPAP Evolution Ventilators (2020-10-05)October 20, 2020 · Medical devices · Medical devices · Type I
- KN95 Face Masks (2020-09-21)October 20, 2020 · Medical devices · COVID - Medical devices · Type I
- Arjo Flat Dynamic Positioning System (2020-10-06)October 16, 2020 · Medical devices · Medical devices · Type II
- Fusion Touchless Infrared Thermometer (2020-09-23)October 16, 2020 · Medical devices · Medical devices · Type II
- NON-CONTACT INFRARED THERMOMETER RN-601 (2020-09-15)October 16, 2020 · Medical devices · Medical devices · Type II
- BLOOD MONITORING UNIT 40 (BMU 40) (2020-09-22)October 16, 2020 · Medical devices · Medical devices · Type II
- Cultura Flex Swabs (2020-09-17)October 15, 2020 · Medical devices · Medical devices · Type II
- MEERA, YUNO & YUNO II (2020-09-11)October 15, 2020 · Medical devices · Medical devices · Type II
- Imager II Angiographic Catheters - 5F Curved Tip Shapes (2020-08-04)October 9, 2020 · Medical devices · Medical devices · Type II
- AMS 700 MS (Momentary Squeeze) Pump (2020-09-24)October 9, 2020 · Medical devices · Medical devices · Type II
- Artis Zeego System (2020-02-17)October 9, 2020 · Medical devices · Medical devices · Type II
- REVOLUTION APEX (2020-09-22)October 9, 2020 · Medical devices · Medical devices · Type II
- INTERNAL PADDLES OPTION FOR DEFIBRILLATOR/MONITOR (2020-09-17)October 9, 2020 · Medical devices · Medical devices · Type II
- CME America BodyGuard Infusion Administration Sets (2020-06-16)October 9, 2020 · Medical devices · Medical devices · Type II
- Trevo XP Provue Retriever (2020-09-28)October 6, 2020 · Medical devices · Medical devices · Type I
- 1500 Flex Heat Moisture Exchanger (2020-09-11)October 6, 2020 · Medical devices · Medical devices · Type I
- Introducer Sheath (2020-09-08)October 2, 2020 · Medical devices · Medical devices · Type II
- 5.5 MM Arthrogarde Hip Access Cannula (2020-09-21)October 2, 2020 · Medical devices · Medical devices · Type II
- HURRICANE RX BILIARY BALLOON DILATATION CATHETER (2020-09-16)October 2, 2020 · Medical devices · Medical devices · Type II
- INFRARED THERMOMETER IR 988 (2020-09-21)October 2, 2020 · Medical devices · Medical devices · Type II
- Uroskop Omnia & Uroskop Omnia Max (2020-09-11)October 2, 2020 · Medical devices · Medical devices · Type II
- PIPELINE FLEX EMBOLIZATION DEVICE (2020-09-08)October 2, 2020 · Medical devices · Medical devices · Type II
- Suture-Based Repair Systems (2020-09-10)September 25, 2020 · Medical devices · Medical devices · Type II
- Spinning Spiros (2020-08-28)September 25, 2020 · Medical devices · Medical devices · Type II
- Autostainer Link (2020-08-31)September 25, 2020 · Medical devices · Medical devices · Type II
- EVOLVE MODULAR RADIAL HEAD SYSTEM - COCR STEM COMPONENT (2020-09-10)September 25, 2020 · Medical devices · Medical devices · Type II
- VICRYL(polyglactin 910) Suture (2020-09-10)September 25, 2020 · Medical devices · Medical devices · Type II
- INFINIX VC-I-SYSTEM & ALPHENIX INFX-8000C - MAIN UNIT (2020-09-11)September 25, 2020 · Medical devices · Medical devices · Type II
- Damon Q2 Gingivally Offset Brackets (2020-01-06)September 25, 2020 · Medical devices · Medical devices · Type II
- Onpoint Scope Procedure Kit & Arthrosimplicity Kit (2020-09-11)September 25, 2020 · Medical devices · Medical devices · Type II
- Kay Pentax Stroboscopy System (2020-09-11)September 25, 2020 · Medical devices · Medical devices · Type II
- Benchmark ULTRA Automated Immunostaining System (2020-09-10)September 25, 2020 · Medical devices · Medical devices · Type II
- REGENEREX PRIMARY TAPER (2020-09-11)September 25, 2020 · Medical devices · Medical devices · Type II
- Spectrum IQ Infusion System with Dose IQ Safety Software (2020-09-04)September 25, 2020 · Medical devices · Medical devices · Type II
- CareLink 2090 Programmer (2020-08-27)September 25, 2020 · Medical devices · Medical devices · Type II
- Velosorb Fast Braided Absorbable Suture (2020-08-21)September 25, 2020 · Medical devices · Medical devices · Type II
- MULTIX IMPACT (2020-08-25)September 25, 2020 · Medical devices · Medical devices · Type II
- Panther Fusion Tube Trays, FAB-15004 (2020-08-04)September 25, 2020 · Medical devices · Medical devices · Type II
- MICROSTREAM CO2 EXTENSION MODULE (2020-06-05)September 25, 2020 · Medical devices · Medical devices · Type II
- SIGMA SPECTRUM Infusion Pump with Master Drug Library (V8 Platform) (2020-09-04)September 25, 2020 · Medical devices · Medical devices · Type II
- LANGSTON DUAL LUMEN PIGTAIL & MULTIPURPOSE A2 CATHETER (2020-08-28)September 25, 2020 · Medical devices · Medical devices · Type II
- DEFIGARD Touch 7 (2019-08-13)September 25, 2020 · Medical devices · Medical devices · Type II
- Rashkind Balloon Catheter Recessed & Double Lumen (2020-09-09)September 22, 2020 · Medical devices · Medical devices · Type I
- Ringloc Bipolar Acetabular Components (2020-09-10)September 18, 2020 · Medical devices · Medical devices · Type II
- Bronchovideoscope (2020-09-01)September 18, 2020 · Medical devices · Medical devices · Type II
- epoc BGEM Test Card (2020-09-02)September 18, 2020 · Medical devices · Medical devices · Type II
- ACCESS SYSTEM & UNICEL DXI 600/800 ACCESS IMMUNOASSAY SYSTEM - UNCONJUGATED ESTRIOL ASSAY (2020-08-31)September 18, 2020 · Medical devices · Medical devices · Type II
- Change Healthcare Radiology Solutions 14.0 (2020-08-25)September 18, 2020 · Medical devices · Medical devices · Type II
- Symbia T & S Systems (2020-08-20)September 18, 2020 · Medical devices · Medical devices · Type II
- Syngo.plaza (2020-08-14)September 18, 2020 · Medical devices · Medical devices · Type II
- Dual Collapser (2020-08-29)September 18, 2020 · Medical devices · Medical devices · Type II
- EV ICD Pivotal Clinical Device (2020-08-13)September 15, 2020 · Medical devices · Medical devices · Type I
- PERCUTANEOUS PIGTAIL NEPHROSTOMY SET (2020-08-31)September 11, 2020 · Medical devices · Medical devices · Type II
- CUSTOM-PAK OPHTHALMIC SURGERY PROCEDURE PACK (2020-08-25)September 11, 2020 · Medical devices · Medical devices · Type II
- INTRA-AORTIC BALLOON CATHETERS (2020-08-28)September 11, 2020 · Medical devices · Medical devices · Type II
- FLARED-END, THORACIC CATHETER (2020-08-27)September 8, 2020 · Medical devices · Medical devices · Type II
- Vega505EE & SwiftHook (2020-08-21)September 8, 2020 · Medical devices · Medical devices · Type I
- PERSEUS A500 & BABYLEO TN500 (2019-07-30)September 4, 2020 · Medical devices · Medical devices · Type II
- FACE MASK (N95/KN95 TYPE RESPIRATOR) (2020-05-22)September 4, 2020 · Medical devices · COVID - Medical devices · Type II
- OES CHOLEDOCHOFIBERSCOPES (2020-08-26)September 4, 2020 · Medical devices · Medical devices · Type II
- Endo GIA Autosuture Universal Loading Unit Articulating (2020-08-18)September 4, 2020 · Medical devices · Medical devices · Type II
- SYNGO.VIA (2020-08-24)September 4, 2020 · Medical devices · Medical devices · Type II
- NeoBurr Carbide Bur (2020-08-12)September 4, 2020 · Medical devices · Medical devices · Type II
- Heater-Cooler Unit HCU 40 (2020-08-17)September 4, 2020 · Medical devices · Medical devices · Type II
- Artis Zee & Artis Q Systems (2020-08-13)September 4, 2020 · Medical devices · Medical devices · Type II
- Medfusion 3500 and 4000 Syringe (2020-08-20)September 1, 2020 · Medical devices · Medical devices · Type I
- DISCOVERY 670 DR & NM/CT 870 CZT & NM 830 (2020-08-14)August 28, 2020 · Medical devices · Medical devices · Type II
- Lactate Dehydrogenase L-P (LDH) (NAD) (2020-08-15)August 28, 2020 · Medical devices · Medical devices · Type II
- Medical Respirator Mask (N95) (2020-07-17)August 28, 2020 · Medical devices · COVID - Medical devices · Type II
- PPE Level D kit (2020-07-23)August 28, 2020 · Medical devices · COVID - Medical devices · Type II
- Endomat Tubing Set (2020-08-14)August 28, 2020 · Medical devices · Medical devices · Type II
- Zenith Alpha Abdominal Endovascular Graft (2020-08-11)August 28, 2020 · Medical devices · Medical devices · Type II
- BD Alaris Pump Module Model 8100 (2020-08-05)August 28, 2020 · Medical devices · Medical devices · Type II
- BD Alaris PC Unit Model 8015 (2020-08-05)August 28, 2020 · Medical devices · Medical devices · Type II
- Alaris System - PCA & Syringe Pump Module (2020-08-05)August 28, 2020 · Medical devices · Medical devices · Type II
- Drill Generic (2020-08-06)August 28, 2020 · Medical devices · Medical devices · Type II
- Merge PACS (2020-08-03)August 28, 2020 · Medical devices · Medical devices · Type II
- KAIYI Non-contact Infrared Thermometer (2020-08-04)August 28, 2020 · Medical devices · Medical devices · Type II
- NitriForce Green Nitrile Disposable Gloves (2020-08-05)August 28, 2020 · Medical devices · COVID - Medical devices · Type II
- Cios Alpha & Spin (2020-07-28)August 28, 2020 · Medical devices · Medical devices · Type II
- Reverse Osmosis Component (2020-07-27)August 28, 2020 · Medical devices · Medical devices · Type II
- Medical Infrared Thermometer (2020-07-23)August 28, 2020 · Medical devices · Medical devices · Type II
- Flexible Intubation Endoscopes (2020-07-27)August 28, 2020 · Medical devices · Medical devices · Type II
- Dimension Vista System ? High Sensitivity Troponin I (TNIH) (2020-07-27)August 28, 2020 · Medical devices · Medical devices · Type II
- Sensis (2020-07-24)August 28, 2020 · Medical devices · Medical devices · Type II
- VITROS XT 7600 Integrated & 3400 Chemistry System (2020-07-24)August 28, 2020 · Medical devices · Medical devices · Type II
- PPE Level D kit (2020-07-23)August 28, 2020 · Medical devices · COVID - Medical devices · Type II
- HeartStart MRx Defibrillator/Monitor (2020-07-24)August 28, 2020 · Medical devices · Medical devices · Type II
- VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack (2020-07-22)August 28, 2020 · Medical devices · COVID - Medical devices · Type II
- Creos xenoprotect 15x20mm (2020-07-21)August 28, 2020 · Medical devices · Medical devices · Type II
- KN95 Face Mask (2020-07-14)August 28, 2020 · Medical devices · COVID - Medical devices · Type II
- KN95 Respirator (2020-07-28)August 28, 2020 · Medical devices · COVID - Medical devices · Type II
- KN95 Face Masks (2020-06-30)August 28, 2020 · Medical devices · COVID - Medical devices · Type II
- MAGEC System (2020-02-13)August 28, 2020 · Medical devices · Medical devices · Type II
- BD SafetyGlide 3ml 25G x 1 (2020-07-29)August 14, 2020 · Medical devices · Medical devices · Type II
- PROTEXIS Latex Micro Surgical Gloves (2020-07-29)August 14, 2020 · Medical devices · COVID - Medical devices · Type II
- BD MAX SARS-CoV-2 Reagents (2020-07-27)August 14, 2020 · Medical devices · COVID - Medical devices · Type II
- Nerveana CN X/RLN Monitoring Kit With 1-Channel Cobra EMG ET Tube, Cobra 1 & 2-Channel EMG ET Tube And 2 Subdermal Needles (2020-07-22)August 14, 2020 · Medical devices · Medical devices · Type II
- POLARSTEM COLLAR Reamer Guide (2020-07-22)August 14, 2020 · Medical devices · Medical devices · Type II
- Protective Mask - KN95 (2020-07-22)August 14, 2020 · Medical devices · COVID - Medical devices · Type II
- Sokinox No Delivering and Monitoring System (2020-07-22)August 14, 2020 · Medical devices · Medical devices · Type II
- PROFEMUR Long Titanium Modular Necks (2020-07-31)August 14, 2020 · Medical devices · Medical devices · Type II
- CARESCAPE R860 (2020-07-17)August 14, 2020 · Medical devices · Medical devices · Type II
- Vitros Chemistry Products System (2020-07-20)August 14, 2020 · Medical devices · Medical devices · Type II
- N-DEX BWC Pink Nitrile Medical Examination Gloves (2020-07-19)August 14, 2020 · Medical devices · COVID - Medical devices · Type II
- Parvovirus B19 IgG ENZYME IMMUNOASSAY (2020-07-17)August 14, 2020 · Medical devices · Medical devices · Type II
- GENESIS II Tibial Base Plate (2020-07-17)August 14, 2020 · Medical devices · Medical devices · Type II
- OmniTom (2020-07-16)August 14, 2020 · Medical devices · Medical devices · Type II
- SICAT Implant V2.0 (2020-07-14)August 14, 2020 · Medical devices · Medical devices · Type II
- Cios Alpha & Cios Spin (2020-07-15)August 14, 2020 · Medical devices · Medical devices · Type II
- Beacon EUS Access System Preloaded 90? Access Needles (2020-07-08)August 14, 2020 · Medical devices · Medical devices · Type II
- Polypectomy Snare (2020-07-06)August 14, 2020 · Medical devices · Medical devices · Type II
- Perseus A500 (2020-07-09)August 14, 2020 · Medical devices · Medical devices · Type II
- KN95 Particulate Respirator (2020-06-25)August 14, 2020 · Medical devices · COVID - Medical devices · Type II
- KN95 Three-Dimensional Protective Respirator (2020-07-13)July 24, 2020 · Medical devices · COVID - Medical devices · Type II
- Kick Navigation System (2020-07-17)July 24, 2020 · Medical devices · Medical devices · Type II
- Infrared Thermometer (2020-07-10)July 24, 2020 · Medical devices · COVID - Medical devices · Type II
- Theracath Spring Wire Epidural Catheter & Epidural Needle Kit (2020-07-08)July 17, 2020 · Medical devices · Medical devices · Type II
- Alaris System (2020-06-30)July 17, 2020 · Medical devices · Medical devices · Type II
- Centrella Smart+ Beds (2020-06-30)July 17, 2020 · Medical devices · Medical devices · Type II
- Progressa (Frame) (2020-06-30)July 17, 2020 · Medical devices · Medical devices · Type II
- SafeStep Huber Needle Set & PowerLoc MAX Power-Injectable Infusion Set (2020-06-19)July 17, 2020 · Medical devices · Medical devices · Type II
- Syngo.Via (2020-06-22)July 17, 2020 · Medical devices · Medical devices · Type II
- 3 Ply Medical Mask (2020-06-25)July 10, 2020 · Medical devices · COVID - Medical devices · Type II
- Active Cord (2020-06-25)July 10, 2020 · Medical devices · Medical devices · Type II
- CARESCAPE ONE (2020-06-24)July 10, 2020 · Medical devices · Medical devices · Type II
- Alinity ci-Series System Control Module (2020-06-26)July 10, 2020 · Medical devices · Medical devices · Type II
- Anti Flu Reusable Protective KN95 N95 Face Mask (2020-06-24)July 10, 2020 · Medical devices · COVID - Medical devices · Type II
- ACTIV.A.C Therapy Unit (2020-06-25)July 10, 2020 · Medical devices · Medical devices · Type II
- Alinity HQ Analyzer & HS Slide Maker Stainer Module (2020-06-18)July 10, 2020 · Medical devices · Medical devices · Type II
- KN95 Protective Mask (Non-Medical) (2020-06-15)July 10, 2020 · Medical devices · COVID - Medical devices · Type II
- Thoracentesis/Paracentesis Tray (2020-06-17)July 3, 2020 · Medical devices · Medical devices · Type II
- Neurosign V4 Intra-operative Nerve Monitor (2020-06-23)July 3, 2020 · Medical devices · Medical devices · Type II
- Face Mask (Public/Surgical Type Respirator) (2020-05-08)July 3, 2020 · Medical devices · COVID - Medical devices · Type II
- Gibco Gurr Buffer Tablets (2020-04-14)July 3, 2020 · Medical devices · Medical devices · Type II
- Prompt Inoculation System-D Inoculation Wand (2019-12-16)July 3, 2020 · Medical devices · Medical devices · Type II
- Ultimax-i (2020-06-29)June 29, 2020 · Medical devices · Medical devices · Type II
- Sterile Solution Media Transport Tubes (2020-06-14)June 26, 2020 · Medical devices · Medical devices · Type II
- DxA 5000 (2020-06-16)June 26, 2020 · Medical devices · Medical devices · Type II
- KN95 Face Mask (2020-06-17)June 26, 2020 · Medical devices · COVID - Medical devices · Type II
- LoFric Origo (2020-06-12)June 26, 2020 · Medical devices · Medical devices · Type II
- VNS Therapy System - VNS Therapy Programming Software Model 3000 1.6 (2020-06-10)June 26, 2020 · Medical devices · Medical devices · Type II
- TEM Insufflation Tubing (2020-06-05)June 26, 2020 · Medical devices · Medical devices · Type II
- Elekta Unity, Philips Marlin Software (2020-05-01)June 26, 2020 · Medical devices · Medical devices · Type II
- KN95 Face Mask (2020-05-11)June 26, 2020 · Medical devices · COVID - Medical devices · Type II
- Skaffold Next Generation Bone Void Filler 5CC, 10CC (2020-04-02)June 26, 2020 · Medical devices · Medical devices · Type II
- Medical Device Respirator recallsJune 23, 2020 · Medical devices · Product safety - COVID - Medical devices
- IcePearl & IceForce Cryoablation Needle (2020-06-04)June 19, 2020 · Medical devices · Medical devices · Type II
- Phantom CS Quick Start Distraction Screw 14mm (2020-06-04)June 19, 2020 · Medical devices · Medical devices · Type II
- Zenith Alpha Abdominal Endovascular Graft (2020-06-02)June 19, 2020 · Medical devices · Medical devices · Type II
- KN95 Face Masks (2020-05-27)June 19, 2020 · Medical devices · COVID - Medical devices · Type II
- Cardinal Health NPWT 300cc Canister With Gel (2020-06-05)June 19, 2020 · Medical devices · Medical devices · Type III
- Syngo.via (2020-06-03)June 19, 2020 · Medical devices · Medical devices · Type III
- Zenith Alpha Abdominal Endovascular Graft (2020-06-02)June 19, 2020 · Medical devices · Medical devices · Type II
- Elecsys Insulin & total P1NP (2020-05-13)June 19, 2020 · Medical devices · Medical devices · Type III
- KN95 Daily Protective Face Mask (2020-05-27)June 19, 2020 · Medical devices · COVID - Medical devices · Type II
- KN95 masks (2020-05-14)June 19, 2020 · Medical devices · COVID - Medical devices · Type II
- VITROS 3600 Immunodiagnostic System-Instrument, 5600 Integrated System-Instrument & XT 7600 Integrated System (2020-05-26)June 19, 2020 · Medical devices · Medical devices · Type II
- HYGENIC Dental Dam Forceps, p/n H01262 (2020-05-21)June 19, 2020 · Medical devices · Medical devices · Type III
- Immulite 2000-Instrument Class 4 & 2000 XPI Instrument (2020-05-20)June 19, 2020 · Medical devices · Medical devices · Type II
- Lasertubus Endotracheal Tube (2020-06-01)June 16, 2020 · Medical devices · Medical devices · Type I
- ACUSON AcuNav Volume ICE catheter (2020-06-05)June 16, 2020 · Medical devices · Medical devices · Type I
- Dexcom G4, G5 & G6 Continuous Glucose Monitoring System (2020-05-29)June 12, 2020 · Medical devices · Medical devices · Type II
- TactiCath Quartz (2020-05-25)June 12, 2020 · Medical devices · Medical devices · Type II
- Arrow AutoCAT 2 & AC3 Optimus Intra-Aortic Balloon Pump (2020-05-22)June 12, 2020 · Medical devices · Medical devices · Type II
- Patient Data Module (PDM) (2020-05-21)June 12, 2020 · Medical devices · Medical devices · Type II
- KN95 Face Mask (2020-05-20)June 12, 2020 · Medical devices · COVID - Medical devices · Type II
- ALLTA KN95 Mask (2020-05-20)June 12, 2020 · Medical devices · COVID - Medical devices · Type II
- KN95 Face Mask (2020-05-21)June 12, 2020 · Medical devices · COVID - Medical devices · Type II
- VITROS Chemistry Products Amyl Slides (2020-05-15)June 12, 2020 · Medical devices · Medical devices · Type II
- CLINITUBES with Capillary Caps & Safe CLINITUBES Blood Sampler (2020-03-03)June 12, 2020 · Medical devices · Medical devices · Type II
- KN95 Face Mask (2020-05-12)June 12, 2020 · Medical devices · COVID - Medical devices · Type II
- SmileFrida TOOTHHUGGER Manual Toothbrush (2020-05-05)June 12, 2020 · Medical devices · Medical devices · Type II
- Liberator (2020-05-01)June 12, 2020 · Medical devices · Medical devices · Type II
- Important safety information for certain respirator masksJune 9, 2020 · Medical devices · COVID - Product safety
- KN95 Respirator (2020-05-22)June 5, 2020 · Medical devices · COVID - Medical devices · Type II
- MAGNETOM SOLA & ALTEA (2020-05-21)June 5, 2020 · Medical devices · Medical devices · Type II
- Proximal Humerus Plate Template 90, 140, 234 mm & Cannulated Screw Tap 6.5, 8.0 mm (2020-05-22)June 5, 2020 · Medical devices · Medical devices · Type III
- Global 5-pc KN95 Face Mask (2020-05-11)June 5, 2020 · Medical devices · COVID - Medical devices · Type II
- Body Fluid Controls (2020-05-18)June 5, 2020 · Medical devices · Medical devices · Type III
- Multifire VersaTack Auto Suture Hernia Stapler 4.0 mm and Multifire VersaTack Auto Suture Hernia Stapler 4.8 mm & Multifire Endo Hernia Auto Suture Straight Hernia Stapler12mm- 4.8 mm and Multifire Endo Hernia Auto Suture Straight Hernia Stapler12mm-...June 5, 2020 · Medical devices · Type III
- Elekta Unity (2020-05-06)June 5, 2020 · Medical devices · Medical devices · Type II
- RayStation (2020-05-17)June 5, 2020 · Medical devices · Medical devices · Type II
- Neo-Tee (T-Piece Resuscitator) (2020-05-01)June 5, 2020 · Medical devices · Medical devices · Type II
- Access TSH (3RD IS) (Calibrators) (2020-05-13)June 5, 2020 · Medical devices · Medical devices · Type II
- Syngo.via VB30A_HF07 (2020-05-14)June 5, 2020 · Medical devices · Medical devices · Type III
- KN95 Face Mask (2020-05-12)June 5, 2020 · Medical devices · COVID - Medical devices · Type II
- Mammomat Revelation (2020-05-11)June 5, 2020 · Medical devices · Medical devices · Type II
- Cobas p 671 (2020-04-29)June 5, 2020 · Medical devices · Medical devices · Type III
- "Ysio Max, Luminos DRF Max, Uroskop Omnia Max & Multitom Rax (2020-04-28) "June 5, 2020 · Medical devices · Medical devices · Type III
- Finger Pluggers 25mm (2020-03-04)June 5, 2020 · Medical devices · Medical devices · Type II
- CME BodyGuard Infusion Pump System (2020-03-06)June 2, 2020 · Medical devices · Medical devices · Type I
- EZ-IO Needle + Stabilizer Kit & Needle Sets (2019-10-11)May 29, 2020 · Medical devices · Medical devices · Type II
- Centrella Bed Frame (2020-05-12)May 29, 2020 · Medical devices · Medical devices · Type II
- N95 Protective Mask (2020-05-12)May 29, 2020 · Medical devices · COVID - Medical devices · Type II
- Alinity C system Optics Assembly (2020-05-20)May 29, 2020 · Medical devices · Medical devices · Type II
- Duodenoscope (2020-04-30)May 29, 2020 · Medical devices · Medical devices · Type II
- ABL800 series analyzer with FLEXQ sampler tray (2020-05-06)May 29, 2020 · Medical devices · Medical devices · Type II
- Michele Sleep Scoring System (2020-05-04)May 29, 2020 · Medical devices · Medical devices · Type III
- Elekta Unity (2020-05-06)May 29, 2020 · Medical devices · Medical devices · Type II
- Xevonta Dialysator LO & HI 18, Gamma (2020-05-06)May 29, 2020 · Medical devices · Medical devices · Type II
- Laborie Pump Tube Set for MMS Libra and Solar Systems (2020-04-14)May 29, 2020 · Medical devices · Medical devices · Type II
- Caesarian (C) Section Packs (2020-01-30)May 29, 2020 · Medical devices · Medical devices · Type II
- Vista 3mL 3% & 6% Sodium Hypo Kit (2019-07-30)May 29, 2020 · Medical devices · Medical devices · Type III
- Artis Pheno System (2020-05-23)May 23, 2020 · Medical devices · Medical devices · Type II
- CVM (2020-05-08)May 22, 2020 · Medical devices · Medical devices · Type III
- VentStar Heated (Neonate), Helix Dual Heated, Helix Heated, Dual H N Plus & Infinity ID Beathing Circuit Heated (Neonate) (2020-05-12)May 22, 2020 · Medical devices · Medical devices · Type I
- Infant/Child Reduced Energy Defibrillation Electrode (2020-05-04)May 22, 2020 · Medical devices · Medical devices · Type II
- Lifepak 500 Automatic External Defibrillator (2020-05-05)May 22, 2020 · Medical devices · Medical devices · Type II
- Dimension Vista System Enzymatic Creatinine Assay (ECREA) & EXL System Enzymatic Creatinine (EZCR) Assay (2020-05-08)May 22, 2020 · Medical devices · Medical devices · Type III
- ADVIA Chemistry System Enzymatic Creatinine_2 (ECRE_2) Assay & Fructosamine (FRUC) Reagent (2020-05-08)May 22, 2020 · Medical devices · Medical devices · Type III
- ShockPulse Transducer (2020-05-06)May 22, 2020 · Medical devices · Medical devices · Type II
- ABL 80 Flex & Flex CO-OX Flex CO-OX OSM (2020-04-26)May 22, 2020 · Medical devices · Medical devices · Type II
- Plasma Collection System 2 & PCS2 (2020-04-09)May 22, 2020 · Medical devices · Medical devices · Type III
- DOA Urine (2019-12-23)May 22, 2020 · Medical devices · Medical devices · Type II
- Ovation iX Abdominal Stent Graft System Platform (2020-05-07)May 15, 2020 · Medical devices · Medical devices · Type II
- MiniMed 630G & 670G Insulin Pump (2020-05-01)May 15, 2020 · Medical devices · Medical devices · Type II
- OminBed & Giraffe Incubator (2020-05-06)May 15, 2020 · Medical devices · Medical devices · Type II
- IMMAGE Immunochemistry System (2020-04-29)May 15, 2020 · Medical devices · Medical devices · Type III
- EliA Stool Extraction Kit 2 (2020-04-30)May 15, 2020 · Medical devices · Medical devices · Type III
- Dimension Vista System Cholesterol Assay (2020-05-01)May 15, 2020 · Medical devices · Medical devices · Type III
- Single Lumen Central Venous Catheter Sets (2020-04-30)May 15, 2020 · Medical devices · Medical devices · Type II
- T2 Tibial Nail System - Locking Screws, Fully Threaded, End Caps & S2 Screws, Locking Screw, Fully Threaded, Sterile (2020-04-30)May 15, 2020 · Medical devices · Medical devices · Type II
- Biograph mMR System (2020-04-30)May 15, 2020 · Medical devices · Medical devices · Type III
- J-Plasma Handpiece, Blade Tip, Pistol Grip, Bovie J-Plasma Precise Open Blade Handpiece Type S & Type P (2020-04-28)May 15, 2020 · Medical devices · Medical devices · Type II
- Ook-Snow, Ook-Cocoon and Ook-Snow MH (2020-05-04)May 15, 2020 · Medical devices · Medical devices · Type III
- Spartan Cube Covid-19 System - Computer & Cube (2020-04-24)May 15, 2020 · Medical devices · COVID - Medical devices · Type III
- PAT CBL 4WIRE AHA SNAP HC (2020-04-23)May 15, 2020 · Medical devices · Medical devices · Type II
- Centry System Hemodialysis Blood Tubing Set (2020-04-23)May 15, 2020 · Medical devices · Medical devices · Type II
- MOBILETT Elara Max (2020-04-23)May 15, 2020 · Medical devices · Medical devices · Type III
- Artiset Blood Tubing Set For Haemodialysis HD SN HC, HD DNL HC & Ultra HDF Post Line (2020-04-23)May 15, 2020 · Medical devices · Medical devices · Type II
- Reverse-Cyte 0.8% (2020-04-22)May 15, 2020 · Medical devices · Medical devices · Type II
- R3 Acetabular System - 0 Hole Acetabular Shell, 3 Hole Acetabular Shell, 0 Hole Ha Coated Acetabular Shell, 3 Hole Ha Coated Acetabular Shell, Multi-Hole Acetabular Shell (2020-04-23)May 15, 2020 · Medical devices · Medical devices · Type II
- 3M Transbond Plus Light Cure Band Adhesive (2020-04-20)May 15, 2020 · Medical devices · Medical devices · Type III
- Anti-D (Monoclonal Blend) (2020-04-16)May 15, 2020 · Medical devices · Medical devices · Type III
- Sysmex XN-10, XN-20 & XN-11 Hematology Analyzers (2020-04-10)May 15, 2020 · Medical devices · Medical devices · Type III
- Heartware Ventricular Assist System - HVAD Implant Kit (2020-04-06)May 15, 2020 · Medical devices · Medical devices · Type II
- Monaco (2020-04-09)May 15, 2020 · Medical devices · Medical devices · Type II
- Synchron Systems Amphetamine Reagent, Synchron Systems Barbiturates Reagent & Synchron Systems Opiate (OP) Reagent (2019-07-15)May 15, 2020 · Medical devices · Medical devices · Type II
- HeartStart XL (2020-04-17)May 8, 2020 · Medical devices · Medical devices · Type II
- Lunar iDXA (2020-04-14)May 8, 2020 · Medical devices · Medical devices · Type III
- Milex Cervical Dilator (2020-04-08)May 8, 2020 · Medical devices · Medical devices · Type II
- Access hsTnI (2020-04-08)May 8, 2020 · Medical devices · Medical devices · Type III
- Container Liquid Waste Set of 3 (2020-04-08)May 8, 2020 · Medical devices · Medical devices · Type III
- XP003/20/P Mammomat Revelation AMC Box: Grey Images (2020-04-08)May 8, 2020 · Medical devices · Medical devices · Type III
- Immunoglobulin M, A & G for use on COBAS INTEGRA 400/400 Plus/800 analyzers & Ceru (Ceruloplasmin) (2020-04-03)May 8, 2020 · Medical devices · Medical devices · Type III
- ADVIA Centaur NT-proBNP (PBNP) & Atellica IM NT-proBNP (PBNP) (2020-03-05)May 8, 2020 · Medical devices · Medical devices · Type II
- CardioLab System - Amplifier (2018-09-17)May 8, 2020 · Medical devices · Medical devices · Type II
- Remisol Advance (2020-04-22)May 8, 2020 · Medical devices · Medical devices · Type II
- ARCHITECT iGentamicin Reagent Kit (2020-04-28)May 8, 2020 · Medical devices · Medical devices · Type II
- Syngo Dynamics (2020-04-27)May 8, 2020 · Medical devices · Medical devices · Type III
- Ysio Max, Luminos DRF Max & Uroskop Omnia Max (2020-04-27)May 8, 2020 · Medical devices · Medical devices · Type III
- Access Sensitive Estradiol Calibrators (2020-04-22)May 8, 2020 · Medical devices · Medical devices · Type III
- NEPHRAL ST 500 (2020-04-24)May 8, 2020 · Medical devices · Medical devices · Type II
- Benchmark Ultra Automated Immunostaining System & Benchmark XT (2020-04-08)May 8, 2020 · Medical devices · Medical devices · Type III
- Monnal Eva Expiratory Valve, Single use & Expiratory Flow Sensor, Single use (2020-03-29)May 8, 2020 · Medical devices · COVID - Medical devices · Type II
- BD BBL Gram Stain Kit & Crystal Violet (2020-04-20)May 8, 2020 · Medical devices · Medical devices · Type II
- Image Navigator (2020-01-02)May 8, 2020 · Medical devices · Medical devices · Type III
- Internal Paddles Option for Defibrillator/Monitor (2020-04-22)May 8, 2020 · Medical devices · Medical devices · Type II
- Cios Alpha & Cios Spin (2020-04-20)May 8, 2020 · Medical devices · Medical devices · Type II
- Chest Bellows- Non-Magnetic Chest Pneumograph (2020-04-22)May 8, 2020 · Medical devices · Medical devices · Type II
- Oscar 2, ABP/CBP System (2020-03-31)May 8, 2020 · Medical devices · Medical devices · Type III
- Magnetom Aera & Skyra (2020-04-16)May 8, 2020 · Medical devices · Medical devices · Type III
- Endocuff Vision (2020-04-16)May 8, 2020 · Medical devices · Medical devices · Type III
- Unauthorized test kits claiming to diagnose or detect COVID-19 put your health at riskMay 7, 2020 · Medical devices · COVID
- Spartan Cube Covid-19 System (2020-05-05)May 6, 2020 · Medical devices · COVID - Medical devices · Type I
- Philips HeartStart MRx Monitor/Defibrillator (2020-04-14)May 1, 2020 · Medical devices · Medical devices · Type III
- Restoration Anatomic Shell (2020-04-16)May 1, 2020 · Medical devices · Medical devices · Type II
- Formula 418 Renal Balloon-Expandable Stent (2020-04-14)May 1, 2020 · Medical devices · Medical devices · Type II
- Carescape One (2020-04-13)May 1, 2020 · Medical devices · Medical devices · Type II
- Optilite Analyser (2020-04-09)May 1, 2020 · Medical devices · Medical devices · Type III
- Ellex Solo-A (2020-04-03)May 1, 2020 · Medical devices · Medical devices · Type II
- Vanguard Knee System & RingLoc Hip System (2020-04-15)May 1, 2020 · Medical devices · Medical devices · Type II
- AQT90 (2020-04-05)May 1, 2020 · Medical devices · Medical devices · Type II
- TRAUMA DIAGNOST (2020-04-13)May 1, 2020 · Medical devices · Medical devices · Type III
- BD PCEA Administration Set (2020-04-08)May 1, 2020 · Medical devices · Medical devices · Type II
- XN CHECK (2020-04-09)May 1, 2020 · Medical devices · Medical devices · Type III
- Prodigy Sleep System HMU & CMU (2020-04-08)May 1, 2020 · Medical devices · Medical devices · Type II
- HealthSmart Digger Dog Steam Inhaler, Margo Moo Steam Inhaler & Mabis Steam Inhaler (2020-04-16)May 1, 2020 · Medical devices · Medical devices · Type II
- Giraffe Shuttle (2020-04-07)May 1, 2020 · Medical devices · Medical devices · Type II
- AZURION 7 M20 (2020-04-03)May 1, 2020 · Medical devices · Medical devices · Type III
- AZURION 7 M20 (2020-04-09)May 1, 2020 · Medical devices · Medical devices · Type II
- CAPTUS 4000e (2020-03-02)May 1, 2020 · Medical devices · Medical devices · Type II
- Atellica CH Total Bilirubin_2 & Direct Bilirubin 2 (2020-02-12)May 1, 2020 · Medical devices · Medical devices · Type III
- Alere NT-proBNP for ARCHITECT Controls & Calibrators (2020-02-26)May 1, 2020 · Medical devices · Medical devices · Type III
- PICC Line Insertion Kit GRH-LF & Pacemaker PK SHSC-LF (2020-04-21)April 29, 2020 · Medical devices · Medical devices · Type I
- BD PosiFlush XS 10 mL (2020-04-17)April 29, 2020 · Medical devices · Medical devices · Type I
- Lifeline & Reviver View AED (2020-04-20)April 29, 2020 · Medical devices · Medical devices · Type I
- Poches a Sang Quadruple (2020-04-09)April 24, 2020 · Medical devices · Medical devices · Type III
- Coagulation Factor V Deficient Plasma (2020-04-04)April 24, 2020 · Medical devices · Medical devices · Type III
- IPS E.max ZirCAD CER/inLab LT A1 C17/5 (2020-04-06)April 24, 2020 · Medical devices · Medical devices · Type III
- TiLoop Mesh (2020-04-10)April 24, 2020 · Medical devices · Medical devices · Type II
- Cobas Infinity Central Lab (2020-04-03)April 24, 2020 · Medical devices · Medical devices · Type III
- Test Thrombin Reagent (2020-04-03)April 24, 2020 · Medical devices · Medical devices · Type III
- Dimension Vista System, Dimension Xpand System & Dimension Exl System - Total Bilirubin Assay (2020-02-21)April 24, 2020 · Medical devices · Medical devices · Type III
- AutoMate 2500 System (2020-03-26)April 24, 2020 · Medical devices · Medical devices · Type II
- Atellica CH A-LYTE Integrator Multisensor (2020-03-27)April 24, 2020 · Medical devices · Medical devices · Type III
- Syngo.Plaza (2020-03-17)April 24, 2020 · Medical devices · Medical devices · Type II
- GEM anastomotic coupler (2020-03-09)April 24, 2020 · Medical devices · Medical devices · Type III
- V60 Ventilator, Symbols Only, with C-Flex and Avaps Option (2020-03-12)April 24, 2020 · Medical devices · Medical devices · Type II
- EZ PRO Swab Kit (2020-04-11)April 21, 2020 · Medical devices · Medical devices · Type II
- Greenlight Laser Fibers (2020-03-30)April 17, 2020 · Medical devices · Medical devices · Type II
- COBAS INTEGRA 400 Plus (2020-03-23)April 17, 2020 · Medical devices · Medical devices · Type III
- ICHEM Velocity Automated Urine Chemistry System and IQ 200 System (2020-03-30)April 17, 2020 · Medical devices · Medical devices · Type II
- Neptune E-SEP Electrode (2020-03-27)April 17, 2020 · Medical devices · Medical devices · Type II
- IMMULITE & 1000 & 2000 System - ACTH Assay (2020-03-27)April 17, 2020 · Medical devices · Medical devices · Type III
- Langston Dual Lumen Pigtail Catheter (2020-03-25)April 17, 2020 · Medical devices · Medical devices · Type II
- Alere Afinion AS100 Analyzer & Alfinion 2 (2020-03-22)April 17, 2020 · Medical devices · Medical devices · Type III
- Bridge Occlusion Balloon (2020-03-30)April 17, 2020 · Medical devices · Medical devices · Type II
- Epix Grasper (2020-03-11)April 17, 2020 · Medical devices · Medical devices · Type II
- HEMASHIELD PLATINUM Woven Double Velour Single Branch Graft & HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Graft Straight (2020-03-24)April 17, 2020 · Medical devices · Medical devices · Type II
- Comprehensive Instrumentation Humeral Tray Taper Extraction Pliers - Replacement Tips (2020-03-17)April 17, 2020 · Medical devices · Medical devices · Type II
- Central Water Plant (CWP) Reverse Osmosis 208V Units (2020-03-23)April 17, 2020 · Medical devices · Medical devices · Type II
- ADVIA Chemistry System-Inorganic Phosphorus (IP) and (PI_C) Assay and Atellica Ch Inorganic Phosphorus (2020-03-30)April 17, 2020 · Medical devices · Medical devices · Type III
- Corflo-Max PEG Kit Pull (2020-03-19)April 17, 2020 · Medical devices · Medical devices · Type II
- FOOTPRINT Ultra PK Suture Anchor,4.5mm; 5.5mm (2020-03-19)April 17, 2020 · Medical devices · Medical devices · Type II
- CCU, Modular, X-Link, Intl, CE (2020-01-20)April 17, 2020 · Medical devices · Medical devices · Type III
- Autolith Lithotripter System - Probes (2020-03-16)April 17, 2020 · Medical devices · Medical devices · Type II
- SensaVue (2020-03-18)April 17, 2020 · Medical devices · Medical devices · Type III
- MassTox Reagent Kit LC-MS/MS Anal of Antidepres/Neuroleptic in Serum/Plasma (2020-03-12)April 17, 2020 · Medical devices · Medical devices · Type II
- Normal Range Trace Elements (2020-03-13)April 17, 2020 · Medical devices · Medical devices · Type III
- VITROS Immunodiagnostic Products TT4 Reagent Pack (2020-03-16)April 17, 2020 · Medical devices · Medical devices · Type III
- Fresenius 2008T Hemodialysis System with CDX (2020-03-12)April 17, 2020 · Medical devices · Medical devices · Type III
- PreludeSYNC Distal Radial Compression Device (2020-03-13)April 17, 2020 · Medical devices · Medical devices · Type II
- Sensor Guidewire (2020-03-09)April 17, 2020 · Medical devices · Medical devices · Type II
- HiRes Ultra CI HiFocus MS & SlimJ Electrode and HiRes Ultra 3D CI with Hi Focus MS & SlimJ Electrode (2020-02-18)April 17, 2020 · Medical devices · Medical devices · Type II
- Dade Ci-Trol 1 (2020-03-11)April 16, 2020 · Medical devices · Medical devices · Type III
- VIROTROL II (2020-03-09)April 16, 2020 · Medical devices · Medical devices · Type III
- MiniMed 630G (2020-03-05)April 16, 2020 · Medical devices · Medical devices · Type III
- FTD Respiratory Pathogens 21 (2020-01-10)April 16, 2020 · Medical devices · Medical devices · Type II
- Biograph mCT-S (40), with True V and Flow-4R (2020-03-10)April 16, 2020 · Medical devices · Medical devices · Type III
- FTD Pneumocystis Jirovecii and FTD Viral Gastroenteritis (2020-01-10)April 16, 2020 · Medical devices · Medical devices · Type II
- ClearCanvas Workstation and ClearCanvas Web Station (2020-02-26)April 16, 2020 · Medical devices · Medical devices · Type II
- Pericardiocentesis Sets and Trays (2020-03-06)April 16, 2020 · Medical devices · Medical devices · Type II
- ImageDrive Clinical (2020-02-26)April 16, 2020 · Medical devices · Medical devices · Type II
- ADVIA 120, 21201 and 2120 Hematology System (2020-03-06)April 16, 2020 · Medical devices · Medical devices · Type III
- ELU KIT Plus Red Cell Elution System (2020-03-06)April 16, 2020 · Medical devices · Medical devices · Type III
- Artis Zee System (2020-03-06)April 16, 2020 · Medical devices · Medical devices · Type III
- RayStation (2020-03-04)April 16, 2020 · Medical devices · Medical devices · Type II
- Cios Alpha & Cios Fusion (2020-03-06)April 15, 2020 · Medical devices · Medical devices · Type III
- Rotor-Gene Q Software (2020-02-03)April 15, 2020 · Medical devices · Medical devices · Type II
- Oxoid BCYE with BMPA (2020-02-25)April 15, 2020 · Medical devices · Medical devices · Type II
- Enterococcus Faecalis Derived from ATCC 51299 (2020-02-21)April 15, 2020 · Medical devices · Medical devices · Type III
- Azurion 7 M20 (2020-03-03)April 15, 2020 · Medical devices · Medical devices · Type II
- StageOne and StageOne Select Bone Cement Spacer Molds (2020-03-04)April 15, 2020 · Medical devices · Medical devices · Type II
- STA - ImmunoDef VIII and STA-Deficient VIII (2020-03-05)April 15, 2020 · Medical devices · Medical devices · Type II
- HeartStart MRX Defibrillator/Monitor (2020-02-26)April 15, 2020 · Medical devices · Medical devices · Type II
- Arrow Midline and PICC ARROWG+ARD Blue Advance Technology (2019-04-25)April 15, 2020 · Medical devices · Medical devices · Type II
- AmniSure ROM Test (2020-03-24)April 15, 2020 · Medical devices · Medical devices · Type II
- Bodyguard Microset (2020-01-14)April 15, 2020 · Medical devices · Medical devices · Type II
- Berhring Nephelometer SystemN Latex CDT Kit (Carb Deficient Transferrin) (2020-03-05)April 15, 2020 · Medical devices · Medical devices · Type III
- MAMMOMAT Revelation (2020-03-05)April 15, 2020 · Medical devices · Medical devices · Type II
- ICHEM Velocity Automated Urine Chemistry System (2019-10-28)April 15, 2020 · Medical devices · Medical devices · Type II
- CUSA Clarity Console C7000 Operators Manual (2019-10-21)April 15, 2020 · Medical devices · Medical devices · Type II
- Fraudulent and unauthorized N95 respirators may not protect consumers against COVID-19April 14, 2020 · Medical devices · COVID - Product safety
- Prismaflex Hemodialysis Unit (2020-03-30)April 8, 2020 · Medical devices · COVID - Medical devices · Type I
- PrisMax Control Unit (2020-03-30)April 8, 2020 · Medical devices · COVID - Medical devices · Type I
- ATELLICA CH 930 Analyzer (2020-02-28)March 13, 2020 · Medical devices · Medical devices · Type II
- ITS4850A Intellivue Telemetry System (2020-02-28)March 13, 2020 · Medical devices · Medical devices · Type II
- VARIANT NBS Newborn Screening System - Sickle Cell Program (2020-02-27)March 13, 2020 · Medical devices · Medical devices · Type III
- LINEAR ARRAY HPV (Human Papilloma Virus) Genotyping Test (2020-02-19)March 13, 2020 · Medical devices · Medical devices · Type III
- ARTIS Pheno (2020-02-27)March 13, 2020 · Medical devices · Medical devices · Type III
- MAGNETOM Sola (2020-02-27)March 13, 2020 · Medical devices · Medical devices · Type III
- MAGNETOM Terra (2020-02-27)March 13, 2020 · Medical devices · Medical devices · Type III
- ADVIA Centaur XPT Instrument (2020-02-26)March 13, 2020 · Medical devices · Medical devices · Type III
- MOBILETT Elara Max (2020-02-25)March 13, 2020 · Medical devices · Medical devices · Type III
- Idylla EGFR Mutation Test (2020-02-22)March 13, 2020 · Medical devices · Medical devices · Type II
- Remel Pathotec CO 100/PK (2020-02-20)March 13, 2020 · Medical devices · Medical devices · Type III
- Sterizone VP4 Sterilizer (2020-02-19)March 13, 2020 · Medical devices · Medical devices · Type II
- XN-10 & XN-11 Modules (2020-02-20)March 13, 2020 · Medical devices · Medical devices · Type III
- Firefly Splashy & Firefly GoTo Seat (2019-09-23)March 13, 2020 · Medical devices · Medical devices · Type II
- Mevatron Linear Accelerators (2020-02-17)March 13, 2020 · Medical devices · Medical devices · Type II
- Access 2 Immunoassay System (2020-02-11)March 13, 2020 · Medical devices · Medical devices · Type III
- Hemochron Signature Elite (2020-01-30)March 13, 2020 · Medical devices · Medical devices · Type III
- Change Healthcare Cardiology ECG Management System (2020-02-09)March 13, 2020 · Medical devices · Medical devices · Type II
- Cybersecurity vulnerabilities associated with some medical devices with Bluetooth Low Energy chipsMarch 11, 2020 · Medical devices · Product safety
- ABL800 FLEX System - Instrument Configurations (2020-02-24)March 6, 2020 · Medical devices · Medical devices · Type II
- Expression MR400 MRI Patient Monitoring System (2020-02-26)March 6, 2020 · Medical devices · Medical devices · Type III
- Atellica CH Ethyl Alcohol (2020-02-19)March 6, 2020 · Medical devices · Medical devices · Type III
- iChem Velocity Urine Chemistry Strips (2020-02-14)March 6, 2020 · Medical devices · Medical devices · Type II
- Syngo.Plaza (2020-02-12)March 6, 2020 · Medical devices · Medical devices · Type II
- Immulite System Estradiol Assay (2020-02-11)March 6, 2020 · Medical devices · Medical devices · Type II
- Elecsys CA 19-9 (2020-02-10)March 6, 2020 · Medical devices · Medical devices · Type II
- Intellijoint KNEE Software Application (2020-02-11)March 6, 2020 · Medical devices · Medical devices · Type II
- Remisol Advance (2019-08-07)March 6, 2020 · Medical devices · Medical devices · Type II
- Atellica IM 1300 & 1600 Analyzer (2020-01-09)March 6, 2020 · Medical devices · Medical devices · Type II
- Ornithine Decaboxylase Tablets (2019-06-20)March 6, 2020 · Medical devices · Medical devices · Type III
- Pipeline Flex Embolization Device and Pipeline Flex Embolization Device With Shield Technology (2020-02-18)March 3, 2020 · Medical devices · Medical devices · Type I
- Sensicare Aloe Surgical Gloves (2020-02-19)February 28, 2020 · Medical devices · Medical devices · Type I
- LIAISON MDX/Integrated Cycler (2020-02-18)February 28, 2020 · Medical devices · Medical devices · Type II
- Force TriVerse Electrosurgical Device Holster (2020-02-12)February 28, 2020 · Medical devices · Medical devices · Type II
- BardPort Slim Titanium Low Profile Implanted Port with Attachable Open End (2020-02-13)February 28, 2020 · Medical devices · Medical devices · Type II
- Architect eAssay CD-ROM (2020-02-14)February 28, 2020 · Medical devices · Medical devices · Type III
- i-STAT CG4+, G3+ & CHEM8+cartridges (blue) (2020-02-04)February 28, 2020 · Medical devices · Medical devices · Type III
- Beckman Coulter AU System - Liquid Urine Chemistry Calibrator (2020-02-05)February 28, 2020 · Medical devices · Medical devices · Type III
- Ysio Radiography X-Ray System - Full Motorized (2020-02-10)February 28, 2020 · Medical devices · Type III
- CLINITEK Status System - Urine Chemistry Analyzer (2020-02-10)February 28, 2020 · Medical devices · Medical devices · Type III
- Monaco RTP System (2020-02-07)February 28, 2020 · Medical devices · Medical devices · Type II
- Ellipse VR and DR (2020-01-22)February 28, 2020 · Medical devices · Medical devices · Type II
- HeartWare Ventricular Assist System - Battery Charger And AC Adapter (2020-01-28)February 28, 2020 · Medical devices · Medical devices · Type II
- Alinity ci-series System Control Module (SCM) (2020-01-29)February 28, 2020 · Medical devices · Medical devices · Type III
- GlideScope Video Laryngoscopes (2020-01-27)February 28, 2020 · Medical devices · Medical devices · Type III
- Artis Pheno (2020-02-07)February 28, 2020 · Medical devices · Medical devices · Type II
- SYNCHRON Systems ISE Electrolyte Reference (2020-01-22)February 28, 2020 · Medical devices · Medical devices · Type II
- Trima Accel Platelet and Multiplasma Sets (2019-12-19)February 28, 2020 · Medical devices · Medical devices · Type II
- Electrosurgical Tip Cleaner (2019-11-22)February 28, 2020 · Medical devices · Medical devices · Type II
- BladderScan BVI 3000 (2020-02-14)February 21, 2020 · Medical devices · Medical devices · Type III
- Alaris System - Server Mobile Systems Manager, PCA Module, Pump & Syringe Pump Module (2020-02-04)February 21, 2020 · Medical devices · Medical devices · Type II
- Olympus Pleuravideoscope LTF-160 (2020-02-03)February 21, 2020 · Medical devices · Medical devices · Type III
- Heater-Cooler Unit 30 System (2020-02-05)February 21, 2020 · Medical devices · Medical devices · Type II
- McGrath X3 Disposable Laryngoscope Blades (2020-01-30)February 21, 2020 · Medical devices · Medical devices · Type III
- Hemospray Endoscopic Hemostat (2020-02-04)February 21, 2020 · Medical devices · Medical devices · Type II
- Monoject Bluntfill with Filter, Hypodermic Safety Needle & 3 Ml Syringe with Hypodermic Safety Needle (2020-01-23)February 21, 2020 · Medical devices · Medical devices · Type II
- Infinix VF-i/SP (2020-01-20)February 21, 2020 · Medical devices · Medical devices · Type II
- Cardinal Health Custom Surgery Packs (2020-01-31)February 20, 2020 · Medical devices · Medical devices · Type II
- Atellica CH Reaction Cuvette Segment (2020-02-17)February 20, 2020 · Medical devices · Medical devices · Type II
- Echo Lumena (2020-01-22)February 14, 2020 · Medical devices · Medical devices · Type III
- Zoli Breathe Nasal Aspirator (2019-12-03)February 14, 2020 · Medical devices · Medical devices · Type II
- ABEL90 Flex Analyzer & ABL90 Flex Plus (2020-01-15)February 14, 2020 · Medical devices · Medical devices · Type II
- BD PrecisionGlideTM Needle 19GX1-1/2IN (2020-01-14)February 14, 2020 · Medical devices · Medical devices · Type III
- Med-RX Wound Care Kit (2020-01-07)February 14, 2020 · Medical devices · Medical devices · Type II
- Retrieval Tools System (2019-04-01)February 14, 2020 · Medical devices · Medical devices · Type II
- Cardinal Health Surgery Packs (2020-01-31)February 11, 2020 · Medical devices · Medical devices · Type II
- Snaplink Buccal Tube, 18° 0° 12° (2020-01-16)February 7, 2020 · Medical devices · Medical devices · Type III
- Centricity Universal Viewer (2020-01-24)February 7, 2020 · Medical devices · Medical devices · Type II
- FilmArray Blood Culture Identification (BCID) panel (2020-01-23)February 7, 2020 · Medical devices · Medical devices · Type II
- IntelePACS (2020-01-21)February 7, 2020 · Medical devices · Medical devices · Type II
- Protease 3 (2020-01-23)February 7, 2020 · Medical devices · Medical devices · Type III
- NucliSENS Lysis Buffer (2020-01-14)February 7, 2020 · Medical devices · Medical devices · Type II
- Bifurcated Insufflation Tubing & Insufflation Tubing (2020-01-13)February 7, 2020 · Medical devices · Medical devices · Type III
- Infinity Central Station (2020-01-07)February 7, 2020 · Medical devices · Medical devices · Type III
- NC Trek RX Coronary Dilatation Catheter (2020-01-29)February 4, 2020 · Medical devices · Medical devices · Type I
- YSIO Max, Luminos DRF, Uroskop Omni Max, Luminos Agile Max (2020-01-17)January 31, 2020 · Medical devices · Medical devices · Type II
- Non-Reinforced Surgical Gowns, Fabric Reinforced Surgical Gowns & Royalsilk Non-Reinforced Surgical Gowns (2020-01-21)January 31, 2020 · Medical devices · Medical devices · Type II
- Artiset Blood Tubing Set for Haemodialysis- HD DNL HC (2020-01-20)January 31, 2020 · Medical devices · Medical devices · Type II
- Wash solution (2020-01-15)January 31, 2020 · Medical devices · Medical devices · Type III
- Heartsine Samaritan PAD (2020-01-13)January 31, 2020 · Medical devices · Medical devices · Type II
- Epidural Catheterization Kit (2020-01-17)January 31, 2020 · Medical devices · Medical devices · Type II
- Rusch Greenlite (2020-01-15)January 31, 2020 · Medical devices · Medical devices · Type II
- Getinge 88-Series Washer/Disinfector (2020-01-16)January 31, 2020 · Medical devices · Medical devices · Type II
- Teleflex Disposable Aortic Punch (2020-01-14)January 31, 2020 · Medical devices · Medical devices · Type II
- Zenith Alpha Spiral-Z Endovascular Leg (2020-01-14)January 31, 2020 · Medical devices · Medical devices · Type II
- Liquichek Cardiac Markers Plus Control LT (2020-01-13)January 31, 2020 · Medical devices · Medical devices · Type III
- Liquichek Cardiac Markers Plus Control LT (2020-01-13)January 31, 2020 · Medical devices · Medical devices · Type III
- Cobas Infinity Central Lab (2020-01-07)January 31, 2020 · Medical devices · Medical devices · Type III
- Michele Sleep Scoring System (2019-10-25)January 31, 2020 · Medical devices · Medical devices · Type II
- Dawson-Mueller Drainage Catheter (2019-12-27)January 31, 2020 · Medical devices · Medical devices · Type II
- Oral-B 3D White Luxe Pulsar 2-Count Battery Toothbrush (2019-12-20)January 31, 2020 · Medical devices · Medical devices · Type III
- Cobas Infinity Central Lab (2019-12-19)January 31, 2020 · Medical devices · Medical devices · Type II
- Evolve Modular Radial Head (2020-01-09)January 24, 2020 · Medical devices · Medical devices · Type III
- Specialist 2 Distal Femoral Cutting Block (2020-01-06)January 24, 2020 · Medical devices · Medical devices · Type II
- Heartmate 3 LVAS Implant Kit (2019-12-02)January 24, 2020 · Medical devices · Medical devices · Type II
- Heartmate 3 LVAS Implant Kit and Modular Cable With Cap (2019-12-03)January 24, 2020 · Medical devices · Medical devices · Type II
- SPY-PHI Drape (2020-01-07)January 24, 2020 · Medical devices · Medical devices · Type II
- Pro-Vent Plus Arterial Blood Sampling Kit (2020-01-07)January 24, 2020 · Medical devices · Medical devices · Type II
- Certain Encode 2-PC EP Healing Abutment (2020-01-10)January 24, 2020 · Medical devices · Medical devices · Type III
- RayStation (2019-12-18)January 24, 2020 · Medical devices · Medical devices · Type II
- JBMH Vaginal Birthing CDS & Voies Centrales (2019-12-31)January 24, 2020 · Medical devices · Medical devices · Type II
- ADVIA Centaur NT-proBNP (PBNP) (2019-12-24)January 24, 2020 · Medical devices · Medical devices · Type II
- VITROS Chemistry Products Calibrator Kit 2 (2019-12-17)January 24, 2020 · Medical devices · Medical devices · Type III
- GORE EXCLUDER System (2019-12-18)January 24, 2020 · Medical devices · Medical devices · Type II
- ADVIA Chemistry System-Enzymatic Creatinine_2 (ECRE_2) Assay (2019-12-24)January 20, 2020 · Medical devices · Medical devices · Type II
- Cobas Integra Tina-quant Soluble Transferrin Receptor (sTFR) (2020-01-07)January 20, 2020 · Medical devices · Medical devices · Type III
- McKesson Cardiology Hemo (2020-01-03)January 20, 2020 · Medical devices · Medical devices · Type III
- LifePak15 Monitor/Defibrillator (2020-01-01)January 20, 2020 · Medical devices · Medical devices · Type II
- Artis Pheno (2020-01-02)January 20, 2020 · Medical devices · Medical devices · Type III
- Vaginal Contraceptive Foam (2019-12-23)January 20, 2020 · Medical devices · Medical devices · Type III
- Arrow Maximal Barrier Drape and r 5 Fr. x 50 cm Arrow Pressure Injectable Two-Lumen PICC Kit (2019-12-24)January 20, 2020 · Medical devices · Medical devices · Type II
- MultiDiagnost Eleva- Flat Detector-Image Detector System - 2019-12-27January 20, 2020 · Medical devices · Medical devices · Type II
- Kangaroo EPump Safety Screw System (2019-12-27)January 20, 2020 · Medical devices · Medical devices · Type II
- Dimension Vista System-Enzymatic Creatinine (ECREA) Assay and Dimension EXL System-Enzymatic Creatinine (EZCR) Assay (2019-12-24)January 20, 2020 · Medical devices · Medical devices · Type II
- ADVIA Chemistry System-LIPASE (LIP) Assay (2019-12-23)January 20, 2020 · Medical devices · Medical devices · Type II
- Alinity hq Analyzer (2019-12-20)January 20, 2020 · Medical devices · Medical devices · Type III
- Hanaulux Sterilizable Handle Hub (2019-12-17)January 20, 2020 · Medical devices · Medical devices · Type II
- LIC2 (2019-11-27)January 20, 2020 · Medical devices · Medical devices · Type III
- Roche Hitachi System 704/717/747 Analyzers (2019-12-05)January 20, 2020 · Medical devices · Medical devices · Type III
- Tensor Knee Brace with Open Patella, One Size (2019-11-19)January 20, 2020 · Medical devices · Medical devices · Type III
- RayStation & RayPlan (2019-11-18)January 20, 2020 · Medical devices · Medical devices · Type II
- 8f Xcela Plus Implantable Ports & 8f Bioflo Plus Implantable Ports (2019-09-18)January 10, 2020 · Medical devices · Medical devices · Type II
- Polysorb Braided Synthetic Absorbable Surgical Suture & Biosyn Glycomer Monofilament Synthetic Absorbable Suture (2019-12-20)January 10, 2020 · Medical devices · Medical devices · Type II
- QUANTA Lite Actin IgG ELISA (2019-12-20)January 10, 2020 · Medical devices · Medical devices · Type III
- QUANTA Lite Histone ELISA (2019-12-20)January 10, 2020 · Medical devices · Medical devices · Type III
- PDS Plus Antibacterial Suture CL, Vl and Vl (Loop) (2019-12-23)January 10, 2020 · Medical devices · Medical devices · Type III
- ASI 2.0 Instruments Calcar Trimmer Shafter (2019-12-23)January 10, 2020 · Medical devices · Medical devices · Type III
- Ball Coarse, Interproximal Fine and Alpen SteriX RC 557 FG 50pk and SS 10pk (2019-12-19)January 10, 2020 · Medical devices · Medical devices · Type II
- Stainless Steel Reprocessing Tray, 8mm Endoscope, IS4000 and 2D Camera Head, IS4000 (2019-12-19)January 10, 2020 · Medical devices · Medical devices · Type III
- Optilite Low Level Albumin Kit (2019-12-19)January 10, 2020 · Medical devices · Medical devices · Type III
- Giraffe Blue Spot PT Lite Phototherapy Systems (2019-12-23)January 10, 2020 · Medical devices · Medical devices · Type II
- Optima CT660 & Revolution EVO (2019-12-18)January 10, 2020 · Medical devices · Medical devices · Type III
- QuickDraw 22 & 25 Venous Cannula (2019-12-17)January 10, 2020 · Medical devices · Medical devices · Type II
- Optipac Refobacin Bone Cement R (2019-12-20)January 10, 2020 · Medical devices · Medical devices · Type III
- Fast-Cath Hemostasis Introducer (2019-12-09)January 10, 2020 · Medical devices · Medical devices · Type III
- CMF Distraction System - Mandible Cloverleaf Foot, AB & BC Craniofacial Distractor Body (2019-11-28)January 10, 2020 · Medical devices · Medical devices · Type III
- Trust Digital In-The-Ear Hearing Aid System (2019-09-18)January 10, 2020 · Medical devices · Medical devices · Type II
- BiliLux (2019-08-21)January 10, 2020 · Medical devices · Medical devices · Type II
- MicroScan Neg/Urine Combo Panel and LabPro Data Management System (2019-05-07)January 10, 2020 · Medical devices · Medical devices · Type II
- and Infinity M540 IACS Monitoring Solution With C700 and Infinity P2500 (2019-04-22)January 10, 2020 · Medical devices · Medical devices · Type II
- Invisalign System (2019-12-12)January 7, 2020 · Medical devices · Medical devices · Type III
- AZURION 7 M20, B12 and B20 (2019-12-18)January 6, 2020 · Medical devices · Medical devices · Type II
- ONE-LINK Needle-free System (2019-12-17)January 6, 2020 · Medical devices · Medical devices · Type II
- Peg Extender/Peg Guide Extender (2019-11-26)January 6, 2020 · Medical devices · Medical devices · Type III
- Locking Drill Guide for 2.3mm Drill (2019-11-26)January 6, 2020 · Medical devices · Medical devices · Type III
- DEFIGARD TOUCH 7 (2019-12-16)January 6, 2020 · Medical devices · Medical devices · Type II
- DIGORA Optime, DIGORA Optime UV (2020-01-04)January 6, 2020 · Medical devices · Medical devices · Type II
- CombiDiagnost R90 (2019-12-11)January 6, 2020 · Medical devices · Medical devices · Type II
- BD Vacutainer Eclipse Blood Collection Needle (2019-12-11)January 6, 2020 · Medical devices · Medical devices · Type II
- Cobas 4800 System Sample Preparation Kit 2 (2019-12-02)January 6, 2020 · Medical devices · Medical devices · Type III
- Video-Laryngoscope amd C-MAC S (2019-12-10)January 6, 2020 · Medical devices · Medical devices · Type II
- Pediaprep & Lemonprep Tubes, and Pediaprep & Lemonprep Single Use Cups (2019-10-06)January 6, 2020 · Medical devices · Medical devices · Type II
- HEALON GV PRO (OVD) (2019-12-02)January 6, 2020 · Medical devices · Medical devices · Type II
- IMRIS iMRX System (2019-11-26)January 6, 2020 · Medical devices · Medical devices · Type III
- Evidence MultiSTAT (2019-06-28)January 6, 2020 · Medical devices · Medical devices · Type III
- Remel BactiDisks Neisseria Gonorrhoeae (2019-12-02)January 6, 2020 · Medical devices · Medical devices · Type III
- Oragene DNA (2018-06-20)January 6, 2020 · Medical devices · Medical devices · Type III
- ADVIA Chemistry System - High Sensitivity C-Reactive Protein(HSCRP) Assay (2019-11-21)January 6, 2020 · Medical devices · Medical devices · Type III
- Evidence MultiSTAT (2019-11-20)January 6, 2020 · Medical devices · Medical devices · Type III
- Pressure Monitoring Kit (Sterile) and Vamp Venous Arterial Blood Management Protection System (2019-11-13)January 6, 2020 · Medical devices · Medical devices · Type III
- SLDL (2019-11-13)January 6, 2020 · Medical devices · Medical devices · Type III
- CRP Vario and Alinity C CRP Vario Reagent Kit (2019-11-13)January 6, 2020 · Medical devices · Medical devices · Type III
- ABL90 Flex - Analyzer and ABL90 Flex Plus (2019-11-07)January 6, 2020 · Medical devices · Medical devices · Type II
- Color Cuff- Sterile Disposable Tourniquet Cuff (2019-11-04)January 6, 2020 · Medical devices · Medical devices · Type II
- Cetrimide Agar (CET) (2019-10-28)January 6, 2020 · Medical devices · Medical devices · Type II
- Cobas H 232 Instruments (2019-10-22)January 6, 2020 · Medical devices · Medical devices · Type II
- UniCel DXH Slidemaker Stainer and UniCel DXH Slidemaker Stainer II Coulter Analysis System (2019-10-02)January 6, 2020 · Medical devices · Medical devices · Type II