BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HawkOne Directional Atherectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPECTRUM INFUSION PUMP

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

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 8, 2010

    45MM ARTICNG LNR CUTR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·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