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    ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Invictus

    FDA UDI
    ALPHATEC SPINE, INC.·00190376271101·MIS Vertical Compressor/Distractor, Body

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018630·Obturator 2.7 x 110mm pyramid tip

    INSTRUMED RETRACTORS

    FDA 510(k)
    FDA Class 2 ·Neurology

    RELINE-IT MODEL RELINE-IT

    FDA 510(k)
    FDA Class 2 ·Dental

    PERSONA TRABECULAR METAL 2 PEG TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code MBH·August 29, 2016

    AFX SYSTEM

    FDA Adverse Event
    Injury ·ENDOLOGIX, INC.·Product code MIH·October 15, 2014

    COULTER® AC *T DIFF 2 ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·June 17, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011

    Ingenia 3.0T-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: 781342 781377

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