Regulatory/Legal
Dec 07, 2016
FDA announces it will consider creating a class of over-the-counter hearing aids and will remove certain requirements in order to make the devices easier to...
Dec 02, 2016
Cook Medical Device: Torcon NB Advantage Beacon Tip Catheters, Royal Flush Plus Beacon Tip High-Flow Catheters, Slip-Cath Beacon Tip Hydrophilic...
Dec 02, 2016
Dexcom Device: The Dexcom G4 PLATINUM REceiver, G4 PLATINUM (Pediatric) Receiver, G4 PLATINUM (Professional) Receiver, G4 PLATINUM Receiver with...
Dec 02, 2016
St. Jude Medical Device: The Fortify, Unify, and Assura Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators...
Dec 02, 2016
Baxter Device: All unexpired lots of the 50 mm 0.2 Micron Filter with product code H93835 Recall reason: According to information on the FDA...
Dec 02, 2016
Alere Device: Alere planned to take the INRatio and INRatio2 PT/INR Monitoring System, including INRatio Test Strips, off the market and to stop...
Dec 02, 2016
Hummingbird Med Devices Device: ABG-HM-1 Hummi Micro-Draw Blood Transfer Device under lot numbers 15180, 15286, 15287, 15300, 15305 Recall reason:...
Dec 02, 2016
HeartWare Device: Batteries used for the HeartWare Ventricular Assist Device (HVAD) with serial numbers BAT000001 to BAT 199999, model number 1650....
Dec 02, 2016
Boston Scientific Device: Certain lots of the Fetch 2 Aspiration Catheter, model number 109400-001. Click here for affected lot numbers. Recall...
Dec 02, 2016
Arrow International Device: Specific models of Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits Recall reason: According to information...