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

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    Alere NT-proBNP for Alinity i

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RS80A Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM ONE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code DBJ·December 5, 2023

    ESSURE

    FDA Adverse Event
    Injury ·BAYER·Product code HHS·November 8, 2014

    HEMOCHRON JR SIGNATURE SYSTEM

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORPORATION·Product code JPA·September 12, 2011

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 30, 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