BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

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    NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS

    FDA 510(k)
    FDA Class 1 ·Radiology

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490482622·INSTRUMENT 6860472 4.0 X 13MM TAP

    PREMISE FLOWABLE

    FDA 510(k)
    FDA Class 2 ·Dental

    Hidrocor, Hidrocharme, and Natural Colors

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·June 10, 2014

    IROX

    FDA Adverse Event
    Malfunction ·GUIDANT ANGLETON/ST. PAUL·Product code NVN·October 7, 2010

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 5, 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