BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    VitalFlow Set with Balance Biosurface

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEVILBISS SMARTLINK II SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    ADVIA CENTAUR

    FDA Adverse Event
    Other ·SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, INC.·Product code JJE·November 10, 2008

    X7000 XENON LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY·Product code FCW·August 8, 2011

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·July 17, 2013

    CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025