BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    FPP IV SECURE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BIODERM SCIENCES WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    0180 INTUITION, 0072 PRECISION

    FDA 510(k)
    FDA Class 2 ·Radiology

    GRANUFLO

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

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·November 20, 2012

    UNKNOWN ZIMMER TRABECULAR METAL STEM

    FDA Adverse Event
    Malfunction ·ZIMMER INC.·Product code HSD·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

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015