20 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EMMA 1.5T MRI System
FDA 510(k)
FDA Class 2
·Radiology
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868246555·
VANGUARD KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304673885·
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304647985·
SMARTDRIVE WHEELCHAIR POWER-ASSIST
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDPOR CUSTOMIZED SURGICAL IMPLANT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
OPTICROSS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·August 22, 2025
OPTICROSS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 23, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 18, 2014
COULTER ACT DIFF ANALYZERS
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·July 8, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008
BIOMET CC CRUCIATE TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 20, 2017
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·October 22, 2020
Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code JWH·May 11, 2018
Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 20, 2018
BIOMET ILOK PRI TIB TRAY 63MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code OIY·October 20, 2020
BIOMET FINNED PRI STEM 40MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code OIY·November 5, 2020
CURAPLEX SELECT MULTIFUNCTION DEFIB PADS - NISSHA VERMED
FDA Adverse Event
Malfunction
·GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES·Product code MKJ·September 30, 2022
Olympus Sterile Optical Laser Fiber, single use and reusable
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021
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