BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    RapidVit™ Oocyte, RapidWarm™ Oocyte

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Vanguard® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304271326·

    Vanguard Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304473126·

    TRIATHLON TRITANIUM TIBIAL BASEPLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRIATHLON P/A CR BEADED #5L

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MBH·January 29, 2024

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013

    COLLEAGUE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 29, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 18, 2014

    TRIATHION

    FDA Adverse Event
    Injury ·HOWMEDICA OSTEONICS CORP.·Product code JWH·December 14, 2023

    MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 LONG HEAD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OVD·December 19, 2022

    TRIATHION COMPONENT

    FDA Adverse Event
    Injury ·HOWMEDICA OSTEONICS CORP.·Product code JWH·December 14, 2023

    DEKA MOTUS AY

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·February 18, 2019

    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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012