8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Veincare
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VARILITE LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML
FDA 510(k)
FDA Class 2
·Orthopedic
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 2, 2025
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
2520274-2013-04587
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·July 22, 2013
S-ICD SYSTEM
FDA Adverse Event
Injury
·CAMERON HEALTH·Product code NVY·November 22, 2015
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