BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    CORIN BIPOLAR PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·February 18, 2014

    L9000 LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·October 18, 2010

    QUATTRODE

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 17, 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