BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture

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

    VySpan™ PCT System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Elfor-L

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TELIGEN IS-1/DF-1 - VR

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008

    TOTALCARE

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

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·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