BEUDAMED
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    QCT-BONE MINERAL ANALYSIS SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDLINE ANTI-EMBOLISM STOCKING

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OPTILENE 4/0 (1.5) 90CM 2XHR26 CV

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL S.A.·Product code GAT·April 25, 2014

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·January 16, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 22, 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