8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALCON SURGICAL PROCEDURE PACKS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REFSTAR WITH QWIKPATCH
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·October 26, 2007
NM APPLICATION SUITE
FDA 510(k)
FDA Class 2
·Radiology
RadiForce MX194
FDA 510(k)
FDA Class 2
·Radiology
PERIGEE
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·December 13, 2012
ATLAS II PLUS DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
PRECISION
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 5, 2010
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025