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

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    ClearCalc Model RADCA V2.6

    FDA 510(k)
    FDA Class 2 ·Radiology

    Portable ECG Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RAPHAEL COLOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GE CSTAT 2000

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code LLZ·December 9, 2008

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 29, 2013

    To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A

    FDA Enforcement
    Class III ·Ongoing·Olympus Corporation of the Americas·May 31, 2023