BEUDAMED
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    Acessa ProVu System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MDF REVISION HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARTHREX MIXING AND DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code ORG·March 5, 2019

    ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code ORG·May 1, 2019

    REFURBISHED COLLEAGUE VOLUMETRIC INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 2, 2008

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 21, 2013

    XENIUM

    FDA Adverse Event
    Injury ·NIPRO CORPORATION·Product code KDI·July 27, 2011

    CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·September 3, 2019

    Ingenia 1.5T S-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 Model: 781347

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