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

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    LacertaMatrix

    FDA 510(k)
    FDA Unclassified ·Unknown

    X-cera Pre-shaded Zirconia Blanks

    FDA 510(k)
    FDA Class 2 ·Dental

    KING I POWERED SCOOTER, MODEL CTL-11

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EON

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code GZB·November 5, 2014

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·September 19, 2011

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·July 15, 2013

    VERSE CORRECTION KEY

    FDA Adverse Event
    Malfunction ·DEPUY SPINE INC·Product code NKB·November 8, 2021

    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