BEUDAMED
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    ShaeferH

    FDA 510(k)
    FDA Class 2 ·Dental

    21.3INCH MONOCHROME LCD MONITOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    NuVasiveNVM5 System

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    DUROM FEMORAL COMPONENT 54 CODE T

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KXA·November 12, 2014

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSETM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·September 9, 2011

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·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