BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    PM830 ELECTRIC MASSAGER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    HISTOPLASMA MYCELIAL #CF10020X

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ILLUMISITE Platform

    FDA 510(k)
    FDA Class 2 ·Radiology

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NTE·June 24, 2014

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·November 4, 2010

    MANTIS REDUCTION BLADES SIZE 2

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code LXH·December 21, 2012

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020