12 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
HyperFlex Bunion Correction System
FDA 510(k)
FDA Class 2
·Orthopedic
GENESIS I CRUCIATE-RETAINING TIBIAL INSERT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC. ORTHOPAEDICS DIV.·Product code HSH·July 23, 1998
MCGHAN 168 ROUND TEXTURED SALINE IMPLANT
FDA Adverse Event
Injury
·MCGHAN MEDICAL CORPORATION·Product code FWM·June 23, 1998
MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CUBEScan BioCon-1100
FDA 510(k)
FDA Class 2
·Radiology
DANEK PLATE AND SCREW
FDA Adverse Event
Injury
·SOFAMOR DANEK MANUFACTURING·Product code KWQ·February 19, 1999
ZY PACING LEAD
FDA Adverse Event
Death
·SULZER OSCOR INC.·Product code DTB·July 13, 1998
THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·November 10, 2014
LIFEPAK(R) 1000 DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·July 23, 2013
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·November 22, 2015
ZIMMER SKIN GRAFT MESHER
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GFD·March 20, 2014
ZIMMER SKIN GRAFT MESHER COMPLETE
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code FZW·January 8, 2014