BEUDAMED
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    MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    VITA Ambria

    FDA 510(k)
    FDA Class 2 ·Dental

    OXYCON

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LIGAMAX 5

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code FZP·June 23, 2014

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·November 8, 2010

    PUMP MMT-722NAB PRDGM INS V2.2 BL EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·July 10, 2008

    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