7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS
FDA 510(k)
FDA Class 2
·Cardiovascular
Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)
FDA 510(k)
FDA Class 2
·Cardiovascular
ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED
FDA 510(k)
FDA Class 3
·Orthopedic
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 30, 2013
ADVANTAGE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 21, 2010
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 15, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 14, 2022