BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    IPL Hair Removal Device (JM-843, JM-865, JM-638)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    RAPIDRESULTS

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EVERCROSS¿ PTA BALLOON

    FDA Adverse Event
    Injury ·EV3 INC.·Product code DQY·September 9, 2011

    RESERVOIR 1.8ML

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·November 10, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·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