BEUDAMED
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    ATLAS™ Expandable Osteotomy Wedge System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALMITECH INC. DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    FFRct

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011

    TEGRESS URETHRAL IMPLANT

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED -3005636544·Product code LNM·November 5, 2014

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·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