BEUDAMED
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    OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP

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

    MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01

    FDA 510(k)
    FDA Class 2 ·Radiology

    MF SAFECATH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MONOCRYL PLUS ANTIBACTERIAL SUTURES

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GAM·March 7, 2013

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·February 15, 2011

    REVEAL LINQ

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code DSI·August 8, 2014

    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