BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    BLOOD RESERVOIR, CARDIOPULMONARY BYPASS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ST FRANCIS HSP TULSA OK 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·December 18, 2012

    OPTIFLUX F250NR, MODEL 0500325E

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Aesculap® SterilContainer(TM) S2 System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ASR ACETABULAR IMPLANT 58

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·June 18, 2014

    SPACELABS MCARE VITAL SIGNS MONITOR

    FDA Adverse Event
    SPACELABS HEALTHCARE·Product code MHX·October 20, 2010

    MINICAP TRANSFER SET

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

    Hand Pack - contains Devon Light Glove Used during surgery

    FDA Enforcement
    Class II ·Completed·Stradis Healthcare, LLC.·July 15, 2015