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

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    QUIDEL ALLERGY SCREEN

    FDA 510(k)
    FDA Class 2 ·Immunology

    PressureWire X Guidewire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ATTAIN OTW

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

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·October 4, 2010

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDIACL·Product code FNL·November 2, 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