11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
AMPCO OPTHALMIC TRAY
FDA 510(k)
FDA Class 2
·Ophthalmic
CROMA Electrosurgical Generator (PRD-EMR-050)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating
FDA 510(k)
FDA Class 2
·Cardiovascular
IMPELLA 5.5
FDA Adverse Event
Death
·ABIOMED, INC.·Product code OZD·December 9, 2025
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
FDA Adverse Event
Malfunction
·ANGIOSCORE, INC·Product code LIT·November 18, 2015
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 13, 2014
ABSOLUTE PRO LL PERIPHERAL SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code FGE·November 21, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 14, 2015
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
FDA Adverse Event
Injury
·ANGIOSCORE, INC·Product code LIT·March 29, 2016
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
FDA Adverse Event
Malfunction
·ANGIOSCORE, INC·Product code LIT·November 26, 2015
MENTOR TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·February 4, 2019