BEUDAMED
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    BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209126743·

    PHILLY BOLTS

    FDA 510(k)
    FDA Class 2 ·Neurology

    VERTICALE GPS Instruments

    FDA 510(k)
    FDA Class 2 ·Neurology

    3002 MASTER BOMS

    FDA Adverse Event
    Death ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 6, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 3, 2012

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code NJE·October 5, 2010

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF 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