BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    Diode Laser Hair Removal System (MBT-Diode Laser)

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

    V.A.C. GRANUFOAM SILVER DRESSING

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

    VAPRO INTERMITTENT CATHETER

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

    BD AUTOSHIELD¿ DUO PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·May 2, 2019

    COAGUCHEK S SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JPA·November 19, 2008

    SD/PD LONG CURVED

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·September 2, 2011

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·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