BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR

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

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704285451·

    InMode Plus System

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

    BILISOFT PHOTOTHERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD ULTRA FINE¿ PEN NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·December 29, 2021

    EASYTRAK 2

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWP·November 11, 2008

    LD304 MATERNITY BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code HDD·August 10, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·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