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

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    MAZZOCCO/FRENCHIK FOLDER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    EBI VERTEBROPLASTY SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN

    FDA 510(k)
    FDA Class 2 ·Immunology

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·June 10, 2014

    THERAKOS XTS PHOTOPHERESIS SYSTEM

    FDA Adverse Event
    Malfunction ·THERAKOS·Product code LNR·November 21, 2012

    COOL PATH DUO 7F, 1304-CP2-7-1.5(5)2-M-TE4BE1AB

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL, IRVINE·Product code OAD·September 21, 2010

    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