BEUDAMED
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    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 4, 2014

    HEARTMATE II LVAS

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·June 2, 2015

    PREMIUM PLUS CEEA 21 INST W/O TILT-TOP

    FDA Adverse Event
    Injury ·USSC PUERTO RICO·Product code GDW·August 17, 2010