7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS
FDA 510(k)
FDA Class 1
·Ophthalmic
7.5 MHZ PEDIATRIC TRANSESOPHAGEAL ECHO (TEE) TRANS
FDA 510(k)
FDA Class 2
·Radiology
BUNNY ELECTRODE/STEALTH ELECTRODE PRE WIRED EEG
FDA 510(k)
FDA Class 2
·Cardiovascular
PRECISION LINK
FDA Adverse Event
Malfunction
·Product code NBW·January 14, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·December 3, 2010
ELLIPSE VR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·July 3, 2014
Presource PBDS, Total Joint, Kit, Circulator
FDA Enforcement
Class I
·Terminated·Cardinal Health, Medical Products & Services·May 15, 2013