BEUDAMED
    9 results · 23ms · Sources: EU EUDAMED, US FDA

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    Highness Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    ALLOX2 TISSUE EXPANDERS

    FDA 510(k)
    FDA Unclassified ·Unknown

    TRIFLANGE II ACETABULAR CUP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCU-CHEK COMFORT CURVE

    FDA Adverse Event
    Malfunction ·*·Product code LFR·February 6, 2006

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 9, 2011

    HIRES 90K ADVANTAGE IMPLANT

    FDA Adverse Event
    Injury ·ADVANCED BIONICS LLC·Product code MCM·July 18, 2013

    BI-MENTUM REVISION CUP 55

    FDA Adverse Event
    Injury ·S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION·Product code MEH·January 24, 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