BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    DIRECT READOUT MODULE ACCESSORY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Shoreline ACS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981130350·Trial 18x15x12mm, 10 Deg Lordosis, w/ Depth Stop

    F&P Brevida™ Nasal Pillows Mask

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 13, 2014

    BIOMESH

    FDA Adverse Event
    Other ·BIOPLATE·Product code JEY·November 29, 2012

    SUTURELASSO, 25 DEGREE TIGHT CURVE LEFT

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code LXH·June 23, 2015

    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