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

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    BIOJECTOR SYRINGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    D-10 Hemoglobin A1c Program

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SPECTRUM INFUSION PUMP

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

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 8, 2010

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·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