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

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    ThinkQA 3

    FDA 510(k)
    FDA Class 2 ·Radiology

    EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    UNK ROTATING HINGE KNEE IMPLANT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·November 12, 2014

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·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