BEUDAMED
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    ARIA II 125 I CORTISOL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Synergy

    FDA UDI
    Rmo, Inc.·00885797100993·ROTH SY 018 HK MAX/3 5-5 20 EA

    ACUMED

    FDA UDI
    Acumed LLC·10806378099601·Fragment Plate Cutter

    INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VICARDIO 12B

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STIMULATOR 8562010 VARI-STIM III 10PK

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·May 9, 2014

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·October 5, 2007

    CLARION

    FDA Adverse Event
    Injury ·ADVANCED BIONICS LLC·Product code MCM·October 19, 2012

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017