BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    UltraPrint-Dental Hard Splint UV

    FDA 510(k)
    FDA Unclassified ·Unknown

    Glidewell TuffSplint™ Appliance Resin

    FDA 510(k)
    FDA Unclassified ·Unknown

    Moda-flx Hemodialysis System and Cartridge

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

    INSIGNIA PLUS

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DXY·November 11, 2008

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·August 10, 2011

    FAST CATH

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL·Product code DYB·July 25, 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