8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DEPUY ASR RESURFACING FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Death
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·November 6, 2014
CORAIL2 LAT COXA VARA SIZE 11
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·August 18, 2011
2.0MM ANGLED AWL
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code OVE·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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