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

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    SENSIBEAD EIA DIGOXIN KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INSERTION TOOL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Electric wheelchair

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·December 2, 2019

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 13, 2014

    RELIANCE SYNERGY WASHER

    FDA Adverse Event
    STERIS CANADA CORPORATION·Product code LDS·November 20, 2012

    XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR - VASCULAR SOLUTIONS·Product code FGE·September 17, 2010

    VERSYS FEMORAL HEAD

    FDA Adverse Event
    Injury ·ZIMMER, TURPEAUX INDUSTRIAL PARK·Product code JDI·March 31, 2016

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017