BEUDAMED
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    CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY

    FDA 510(k)
    FDA Class 2 ·Radiology

    OPUS FERRITIN TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    STRATO PORT INTRODUCER KT(10 FR) LPS 5015/MODIFIED

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 6, 2013

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP·Product code FPA·December 22, 2010

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·July 21, 2014

    VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·February 19, 2020