12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BioPlex 2200 Lyme Total
FDA 510(k)
FDA Class 2
·Microbiology
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304271166·
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304465893·
DIVERSATEK HEALTHCARE INC
FDA registration
DIVERSATEK HEALTHCARE INC·26 products·🇺🇸 United States
VIGNET TELEHEALTH MANAGER
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING
FDA 510(k)
FDA Class 2
·Radiology
2183446-1999-00001
FDA Adverse Event
Injury
·Product code FAT·March 30, 1999
MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 LONG HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVD·December 19, 2022
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 18, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 28, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·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