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

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    Invictus Bands System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    The Orthodontic Store

    FDA UDI
    Young Innovations, Inc.·00843471142745·Ten-Ties, Emerald Green

    Truliant

    FDA UDI
    Exactech, Inc.·10885862556813·TRIAL, TIBIAL INSERT, PSC, SIZE 1.5

    NeoFuse HA Enhanced PLIF/TLIF

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Dental Scaler and Air Polisher

    FDA 510(k)
    FDA Class 2 ·Dental

    ENDOTAK RELIANCE G

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·August 11, 2011

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·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