BEUDAMED
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    RODIN Titan 3D Resin

    FDA 510(k)
    FDA Class 2 ·Dental

    STANDARD IMAGING E.IMRT CALCULATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    hyperion X5, NewTom GO, X-RADiUS COMPACT

    FDA 510(k)
    FDA Class 2 ·Radiology

    OEC 9900 ELITE

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC·Product code JAA·November 17, 2008

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·September 9, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·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