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

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    Vivo 1, Vivo 2

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Chemical Indicator for Steam

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·November 10, 2014

    MESH

    FDA Adverse Event
    Injury ·Product code FTL·September 3, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·July 22, 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