BEUDAMED
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    Luer-Split MAJ-2092

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

    NYOrtho APEX CORE Wedge Pommel Wheelchair Cushion Gel-Foam 24x18x4x2

    FDA UDI
    N.Y. ORTHOPEDIC USA, INC.·00811677010557·For patients requiring hip positioning that are...

    NYOrtho APEX CORE Wedge Wheelchair Cushion Gel-Foam 24x18x4x2

    FDA UDI
    N.Y. ORTHOPEDIC USA, INC.·00811677010472·For patients that are inclined to slide forward...

    NORIAN SRS FAST SET PUTTY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STARBAND, STARLIGHT

    FDA 510(k)
    FDA Class 2 ·Neurology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 9, 2011

    LH 500 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 22, 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