13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General Hospital
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304271623·
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304473225·
INSTRUMENT TRAY
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896019584·INSTRUMENT TRAY ANODIZED ALUMINUM
CENTURION PRESSURE INJECTABLE EXTENSION SET
FDA 510(k)
FDA Class 2
·General Hospital
STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SOLID SCREWDRIVER, SMALL
FDA Adverse Event
Malfunction
·CONVENTUS FLOWER ORTHOPEDICS·Product code HXX·August 17, 2021
AVIATOR ASSY TWO LEVEL PLATE SIZE 28
FDA Adverse Event
Injury
·STRYKER SPINE-FRANCE·Product code KWQ·October 17, 2016
ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FRN·September 27, 2017
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 18, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 29, 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