BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    Prodeon Urethral Sheath System

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

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690124467·Modular Offset Stem 15mm x 75mm x 2mm

    AXIOS Stent and Delivery System

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

    ANSPACH KNOTLESS ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 15, 2014

    ASR UNI FEMORAL IMPL SIZE 41

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 18, 2011

    CODEMASTER XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code LDD·July 15, 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