BEUDAMED
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    Diode laser Treatment System (K18)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Nonin OTC Pulse Oximeter Model 3250

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Miha Bodytec II

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·August 10, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 10, 2014

    COULTER® LH 780

    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