BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    HISTOLOGY PARAFFIN

    FDA 510(k)
    FDA Class 1 ·Pathology

    Restore PACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    MAMMOPAD RADIOLUCENT CUSHION

    FDA 510(k)
    FDA Class 1 ·Radiology

    MYOCARDIAL LEAD

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

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 8, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·December 7, 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