20 results · 24ms · Sources: EU EUDAMED, 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