BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    Omni Legend

    FDA 510(k)
    FDA Class 2 ·Radiology

    L1-PRO SYSTEM

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

    NuVasive CoRoent System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COBAS INTEGRA 400

    FDA Adverse Event
    Malfunction ·ROCHE INSTRUMENT CENTER AG TEGIMENTA·Product code JJE·November 19, 2008

    LIBERTY CYCLER SET, DUEL PATIENT CONNECT

    FDA Adverse Event
    Malfunction ·REYNOSA MFG.·Product code FKX·August 19, 2011

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 22, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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