15 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Electrosurgical Generator
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304271630·
INSTRUMENT TRAY
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896084087·INSTRUMENT TRAY ANODIZED ALUMINUM BLACK/RED (FO...
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304473201·
ADDEV Materials Healthcare
FDA registration
ADDEV Materials Healthcare·7 products·🇺🇸 United States
VENOFER PUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EXSALT T7 WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
MAXIM INTERLOK FIXED I-BEAM TIBIAL PLATE WITH LOCKING BAR
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code JWH·February 15, 2018
VANGUARD CR FEMORAL LEFT INTERLOK
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code JWH·February 15, 2018
BIOMET SERIES A STANDARD PATELLA
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code JWH·February 15, 2018
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 18, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·July 11, 2011
VANGAURD CR FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·September 28, 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