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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