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

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    Prophecy Incompass Surgical Planning System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Vinyl patient examination glove, Powder Free

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VECTORVISION SPINE

    FDA 510(k)
    FDA Class 2 ·Neurology

    ENDOTAK C TRANSVENOUS DEFIBRILLATION LEAD

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS·Product code LWS·May 8, 1997

    VENTAK PRX III IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS·Product code LWS·May 8, 1997

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·December 5, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 19, 2011

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITJ·July 29, 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