BEUDAMED
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    NEUROPACE BURR HOLE COVER

    FDA 510(k)
    FDA Class 2 ·Neurology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517575029·CoRoent Ant TLIF Ti, 14x11x36mm 8°

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515018853·Roch-Ochs Hemo Fcps, cvd, 1x2 tth, 9 1/2"

    BD PEGASUS¿ BL 22GA X 1.00IN QSYTE-CAP Y

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·May 16, 2019

    DENTIUM CO., LTD. IMPLANTIUM

    FDA 510(k)
    FDA Class 2 ·Dental

    D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X80MM X 125

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 17, 2012

    BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·November 28, 2022

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    SM204 M-SERIES W/BIG WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·June 1, 2011

    ACRYSOF

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·August 22, 2008

    BD FACS 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·June 30, 2020

    BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·May 8, 2025

    Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Version Number: R2.0

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 13, 2022

    Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·November 17, 2021