7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRANS/R NEEDLE GUIDE
FDA 510(k)
FDA Class 2
·Radiology
HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE)
FDA 510(k)
FDA Class 2
·Orthopedic
ENTRIMIT GRAVITY FEEDING SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COBAS INTEGRA 800
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·June 16, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 19, 2010
UNKNOWN ZIMMER HIP
FDA Adverse Event
Injury
·ZIMMER INC·Product code JDI·December 12, 2012
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026