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

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    NeuroSpan Bridge

    FDA 510(k)
    FDA Class 2 ·Neurology

    CHLORAPREP ONE STEP

    FDA Adverse Event
    Malfunction ·CAREFUSION 213, LLC 0113·Product code KXF·March 8, 2022

    Red2Green Reusable Sharps Container

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS

    FDA Adverse Event
    Injury ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019

    ARCHITECT IPTH REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code CEW·January 25, 2021

    PUMP MMT-522NAL PRDGM INS V2.2 CL EN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·December 2, 2008

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·August 3, 2011

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 29, 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