We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA has provided devicemakers with nitty-gritty details on how to set up and use the Global Unique Device Identification Database, a key component of the universal tracking system set to take effect for Class III implantable devices on Sept. 24. Read More
Coronary device company HeartWare International said Wednesday that it received an FDA warning letter related to the company’s Miami Lakes, Fla., manufacturing facility. Read More
Cook Vascular was handed an FDA warning letter for marketing the Cook Evolution RL and the Shortie RL Bi-directional Dilator Sheath Sets without marketing clearance or approval. Read More
BALTIMORE — Devicemakers in the process of setting unique device identification codes with the FDA may want to bake in some extra time, agency officials say. Read More