BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM W/DOPPLER

    FDA 510(k)
    FDA Class 2 ·Radiology

    MICRO STIX #011-010-5000 & HOLDER#5100

    FDA 510(k)
    FDA Class 1 ·Microbiology

    KAPSS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 25, 2014

    L9000 LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·November 1, 2010

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·January 2, 2013

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

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