BEUDAMED
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    DeepRhythmAI

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    S-ROM

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295129110·11/13 S-ROM TRIAL 40mm -3

    DyeVert Contrast Modulation System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ACRYSOF RESTOR

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. /HUNTINGTON·Product code MFK·December 5, 2008

    DEXTRUS 4135

    FDA Adverse Event
    Other ·BIOTRONIK SE 7 CO. KG·Product code NVZ·August 31, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·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