BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    Momcozy Nasal Aspirator (BN007)

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

    ArcadiusXP C Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANCHOR PLUS/NEO ANCHOR PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    VITALITY EL

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

    GOBED II MED/SURG BED

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

    ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FRN·July 16, 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