BEUDAMED
    7 results · 23ms · Sources: EU EUDAMED, US FDA

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    ZywieZ3 Sensor & Adhesive

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CT PERFUSION 4

    FDA 510(k)
    FDA Class 2 ·Radiology

    Overlapped Compression Therapy

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PUMP MMT-722NAP PRDGM INS V2.2 PL EN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·December 4, 2008

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON SARL·Product code OTN·July 29, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014