BEUDAMED
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    KardiaPSI Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arrow Pressure Injectable Midline Catheter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CoNextions TR Tendon Repair System

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

    INSIGNIA ULTRA

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

    CENTRA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·August 11, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 30, 2013

    LEEP PRECISION GENERATOR

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HGI·May 14, 2024

    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