BEUDAMED
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    LOGIQ P9 and LOGIQ P7

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801

    FDA 510(k)
    FDA Class 2 ·Hematology

    PTA-DUO PTA BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 23, 2025

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    SPRINT QUATTRO

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·October 10, 2014

    UNICEL DXC 600I SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JGS·June 17, 2011

    Ingenia 1.5T Evoluton- 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 Number: 781315

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·September 1, 2021

    Ingenia 1.5T Evolution-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: 781315

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