8 results
·
34ms
·
Sources: EU EUDAMED, US FDA
O2 CONNECTOR
FDA 510(k)
FDA Class 1
·Anesthesiology
BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
World Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
ADAPTER SLEEVES 12/14 +2
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·April 30, 2014
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 10, 2012
ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Injury
·COOK INC·Product code MIH·July 26, 2010
1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code JEY·March 12, 2018
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 26, 2017