BEUDAMED
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    PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517085433·

    HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCU-CHEK ® PERFORMA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·November 10, 2014

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·September 2, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·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