15 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Access Cortisol; DxC 500i Clinical Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Artman Instruments
FDA UDI
Wise Linkers, LLC·D1272421901·Small Dental Straight Extraction Luxating Eleva...
Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MODEL 6416 TEMPORARY PACING LEAD SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
OXF ANAT BRG LT MD SIZE 4 PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·January 10, 2019
OXF TWIN-PEG CMNTD FEM MD PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·January 10, 2019
OXF TWIN-PEG CMNTD FEM SM PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·December 19, 2023
OXF UNI TIB TRAY SZ B RM PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·December 19, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 11, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·July 23, 2013
OXF UNI TIB TRAY SZ B RM PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·December 27, 2023
OXF TWIN-PEG CMNTD FEM SM PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·December 27, 2023
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