BEUDAMED
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    CEDIA N-ACETYLPROCAINAMIDE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72

    FDA 510(k)
    FDA Class 2 ·Hematology

    Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code GJS·May 29, 2014

    2520274-2013-10024

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code MNI·February 13, 2013

    HUDSON COMFORT FLO HUMIDIFICATION SYSTEM

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTT·December 17, 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