BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)

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

    Sophono Bone Conduction Systems (S) Configuration and (M) Configuration

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    X-TRA FIL

    FDA 510(k)
    FDA Class 2 ·Dental

    TRUERESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·November 12, 2014

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·August 3, 2011

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    UNKNOWN·Product code IKX·July 29, 2013

    Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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