9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
HYBRID CAPTURE II CT/GC TEST
FDA 510(k)
FDA Class 2
·Microbiology
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981567·anteriors; shade A3 light; mould CL2
VERTEBRON SSP CERVICAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
API ZYM
FDA 510(k)
FDA Class 1
·Microbiology
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·October 29, 2025
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 27, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·January 31, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·August 5, 2014
DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
FDA Enforcement
Class I
·Terminated·Synthes, Inc.·August 27, 2014