Regulatory/Legal
Dec 09, 2016
These were the most important guidance documents of the year for medical device manufacturers. Gordon MacFarlane, PhD, RAC and Cynthia Nolte, PhD, RAC This...
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...