BEUDAMED
    8 results · 34ms · Sources: EU EUDAMED, US FDA

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    ACU-DERM TRANSPARENT IV DRESSING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)

    FDA 510(k)
    FDA Class 2 ·Dental

    GALILEO NT

    FDA 510(k)
    FDA Class 2 ·Neurology

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·May 31, 2014

    GORE BIO-A TISSUE REINFORCEMENT

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code FTL·November 12, 2012

    PRECISE OTW NITINOL STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIM·September 23, 2010

    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