17 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS
FDA 510(k)
FDA Class 2
·Orthopedic
Biomet Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304009691·
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868558757·
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515018099·Coller-Crile Fcps, Delicate jaw, curved, 7 1/4"
LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES,
FDA 510(k)
FDA Class 2
·Orthopedic
NEUROGUIDE ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MAX PRI DCM TIB BRNG12X71/75MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·May 15, 2018
UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·June 3, 2013
UNKNOWN DEPUY TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 22, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008
TRIFORCE¿ PERIPHERAL CROSSING SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·August 1, 2015
UNKNOWN FEMORAL COMPONETN
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 24, 2023
BIOMET FINNED PRI STEM 40MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 24, 2023
TI LOW PROFILE SCREW 6.5X25MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 15, 2018
TI LOW PROFILE SCREW 6.5X40MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 15, 2018
VANGUARD KNEE SYSTEM CR FEMORAL LT 60
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·September 27, 2017
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