BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    SpineSite Endoscope System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ISOLA RODS, SCREWS

    FDA Adverse Event
    Injury ·ACROMED CORP·Product code JDN·February 12, 1998

    ENCORE HUMERAL SHOULDER STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 10, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 23, 2013

    DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE·Product code KYG·November 22, 2015

    AIR DERMATOME HANDPIECE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code GFD·February 12, 2014

    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