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Hong Kong’s Department of Heath issued safety warnings for Boston Scientific Ingevity MRI endocardial pacing leads and Percuflex Urinary Diversion stents, Draeger Medical GmbH Oxylog 3000 and Oxylog 3000plus ventilators, and Brainlab radiation treatment software, all of which may have manufacturing or production defects. Read More
Hoggan Scientific LLC was hit with a Form 483 after an inspection revealed a lack of adequate procedures for design control, corrective and preventive actions, complaint evaluation, and other issues. Read More
Final guidance on reducing cross-contamination from irrigation valves and accessories for flexible gastrointestinal endoscopes adds a new section on testing for backflow prevention. Read More
The European Commission is planning to lift a July 22, 2019 deadline and allow certain second-hand and refurbished devices that contain hazardous substances to continue to be marketed in the EU beyond that date. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a safety alert based on a notice issued by Ascensia Diabetes Care Holdings. Read More
Australia’s Therapeutic Goods Administration has issued safety alerts for Medtronic Australasia’s cardiac resynchronisation therapy defibrillators (CRT-Ds), Fresenius Medical Care Australia’s Seep-Safe tubing systems. Read More
Hong Kong’s Department of Health issued safety alerts for Synthes GmbH’s PFNA Blade Impactor, Boston Scientific’s Imager II Angiographic Catheter and Express LD Biliary Stent. Read More
Almost a year after its draft guidance on communicating new information about medical device safety issues, the FDA has published final guidance that makes some relatively minor changes. Read More
Almost a year after its draft guidance on communicating new information about medical device safety issues, the FDA has published final guidance that makes some relatively minor changes. Read More