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Two medical device experts use a Hyman, Phelps & McNamara post to urge FDA to provide additional guidance to ease what they see as...[ Price : $8.95]
News outlets report that Johns Hopkins surgeon Marty Makary is likely to be nominated by president-elect Donald Trump as the next ...[ Price : $8.95]
Academic medical center authors writing in the Annals of Internal Medicine say litigation involving the Cook Celect IVC filter dem...[ Price : $8.95]
Two stakeholders request changes to an FDA draft guidance on predetermined change control plans for medical devices.[ Price : $8.95]
FDA says the Draeger recall correction of its Atlan A350 and A350XL anesthesia workstations is Class 1.[ Price : $8.95]
Smiths Medical recalls (Class 1) its CADD-Solis Li-ion Rechargeable Battery Packs to update instructions for use due to a potentia...[ Price : $8.95]
Federal Register notice: FDA determines that Endos Fortesta (testosterone) gel was not withdrawn due to safety or effectiveness re...[ Price : $8.95]
FDA publishes a guidance with information on third-party review of 510(k)s and emergency use authorizations.