9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Poly Clear
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304438545·
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304479999·
ML24000 UVA-1 PHOTOTHERAPY UNIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ORTHOSCAN MOBILE DI MINI C-ARM
FDA 510(k)
FDA Class 2
·Radiology
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008
ENDOPATH** XCEL* TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·July 29, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 22, 2013
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