BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

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    TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PROD

    FDA 510(k)
    FDA Class 1 ·Hematology

    CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Erbe’s CO2 Tubing/Cap Sets

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 23, 2014

    CS300

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·November 29, 2012

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·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