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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    encevis (2.1)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464057689·OTICON PLAY PX 2 MINIRITE T C063

    IONOSTAR MOLAR

    FDA 510(k)
    FDA Class 2 ·Dental

    CereLink ICP Monitor

    FDA 510(k)
    FDA Class 2 ·Neurology

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DRY·August 17, 2011

    MUSTANG?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code FGE·November 10, 2014

    SPEEDSTITCH SUTURING DEVICE

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code GAT·July 17, 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