BEUDAMED
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    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Wolf445nm

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    RANDOX METHADONE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ASAHI APS DIALYZERS

    FDA Adverse Event
    Injury ·ASAHI KASEI MEDICAL CO., LTD.·Product code KDI·March 1, 2013

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code NVY·August 8, 2014

    CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·February 15, 2011

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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

    PM 1260 ASSURITY + 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