BEUDAMED
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    Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Infinity Gateway Suite

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FINELINE II

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·November 11, 2008

    LD304 MATERNITY BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code HDD·August 10, 2011

    ENDURON 10D 56 OR 68ODX28ID

    FDA Adverse Event
    Injury ·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code HRY·July 30, 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