BEUDAMED
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    Amydi-med Disposable Non-invasive EEG electrodes

    FDA 510(k)
    FDA Class 2 ·Neurology

    PLATINUMGMT IPL SYSTEM CLOUD

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

    E-Z SCAN AB5500+

    FDA 510(k)
    FDA Class 2 ·Radiology

    POLARIS SPVA KIT PREATTACHED/BO19-10

    FDA Adverse Event
    Other ·SOPHYSA·Product code JXG·December 17, 2007

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

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

    7MM FLUTED BALL, MIA 20CM

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HSZ·July 17, 2013

    ACCOLADE DR SL MRI (Model L311)

    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