BEUDAMED
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    Aeka Imaging

    FDA 510(k)
    FDA Class 2 ·Radiology

    CLEARFIX

    FDA UDI
    Medos International Sàrl·10886705012626·CLEARFIX Meniscal Rasp Straight-Up / 90 Degrees...

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011253111200·ceraMotion® Lf Dentin Modifier Chroma A, 20 g /...

    STA-CEPHASCREEN KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    TOUAREG CloseFit™ UNP 2.75mmD

    FDA 510(k)
    FDA Class 2 ·Dental

    CORTRAK 2 ENTERAL ACCESS SYSTEM

    FDA Adverse Event
    Injury ·CORPAK MEDSYSTEMS·Product code KNT·October 7, 2014

    ACCESS 2 IMMUNOASSAY SYSTEM

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

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·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