BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    SS-A/SS-B AUTOANTIBODY TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    Lelo Hex Natural Rubber Latex Condom

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    AHMED GLAUCOMA VALVE, MODEL M4

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·June 10, 2014

    INSIGNIA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 7, 2010

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MED CORP·Product code MKJ·October 26, 2012

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012