BEUDAMED
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    LuxCreo Flexible Partial Denture Resin

    FDA 510(k)
    FDA Class 2 ·Dental

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517632210·CoRoent Ant TLIF Ti, 15x13x36mm 15°

    MODIFICATION TO THERMAGE THERMACOOL SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PUMP MMT-512NAB PRDGM INSULIN BL EN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·December 2, 2008

    D-M 2.0MM BEADED CABLE SET VIT

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS CORK·Product code KTT·August 3, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·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