BEUDAMED
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    BEHRING POLAROID OPUS THEOPHYLLINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PiCCO catheter

    FDA UDI
    Maquet Critical Care AB·27325710017047·

    PERINATAL COMPUTER SYS MODEL 100A & 100B

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

    OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OVATION ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·TRIVASCULAR, INC.·Product code MIH·June 19, 2014

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 28, 2010

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL NEUROMODULATION·Product code LGW·December 18, 2012

    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