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

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    FIBRINOGEN ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    Stabilizer Arm Curved

    FDA UDI
    KOROS U.S.A., INC.·10840199538710·Stabilizer Arm Curved

    BIOTRACK APTT REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Hematology

    SPLASH GUARD GOGGLE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024143784·

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·May 20, 2014

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2010

    UNKNOWN RIGHT HIP REJUVENATE NECK

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·December 27, 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