BEUDAMED
    8 results · 29ms · Sources: EU EUDAMED, US FDA

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    aprevo® anterior lumbar interbody fusion device with interfixation

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DISCOVERY IQ

    FDA 510(k)
    FDA Class 2 ·Radiology

    PATHFINDER

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 29, 2025

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·November 10, 2014

    AC POWER MODULE

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 9, 2011

    ALTRUA

    FDA Adverse Event
    Malfunction ·GUIDANT PUERTO RICO BV·Product code NVZ·July 22, 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