BEUDAMED
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    Urbanek Device

    FDA 510(k)
    FDA Unclassified ·Unknown

    BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK

    FDA 510(k)
    FDA Class 2 ·Dental

    AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 14, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 30, 2011

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008

    IMPELLA RP

    FDA Adverse Event
    Injury ·ABIOMED, INC.·Product code OJE·November 7, 2017

    Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781341 781396

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021