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

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    Electric wheelchair (JJW-7002, JJW-7003)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    General Radiography CXDI-CS01

    FDA 510(k)
    FDA Class 2 ·Radiology

    SafeOp 2: Neural Informatix System

    FDA 510(k)
    FDA Class 2 ·Neurology

    VITALITY 2 VR

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

    AFFINITY 4

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code HDD·August 11, 2011

    2520274-2013-04810

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·July 30, 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