BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    Implantmed Plus II & Piezomed Plus II Module

    FDA 510(k)
    FDA Class 2 ·Dental

    Surgical Masks, Model SNN200640 & MN112

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

    Optetrak One Logic Femoral Components

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·December 9, 2021

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·November 11, 2008

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FPO·August 10, 2011

    UNK

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·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