10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Total Knee Application (TKA)
FDA 510(k)
FDA Class 2
·Neurology
METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET
FDA 510(k)
FDA Class 2
·Orthopedic
VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE
FDA 510(k)
FDA Class 2
·Microbiology
CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·November 12, 2018
ENVEO R DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 2, 2025
VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-GP75 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code LON·January 14, 2019
OSCILL-SAW-ATTACHM F/532.001 532.010 532
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·October 6, 2014
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·June 3, 2011
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 3, 2013
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026