BEUDAMED
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    TRACHEOSTOMY TUBE AND CUFF

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·34546540244438·BONE SCREWS, CROSS-FIT, SELF-TAPPING

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123106·K-WIRE - DOUBLE TROCAR 1.2mm DIA x 100mm

    Malibu

    FDA UDI
    Seaspine Orthopedics Corporation·10889981080686·Rod Pusher

    MICROCATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP

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

    LIFEGUARD NON-CORING SAFETY INFUSION SET

    FDA Adverse Event
    Malfunction ·VYGON (CHURCHILL MEDICAL SYSTEMS)·Product code FPA·November 17, 2010

    4.5 HEALIX ADVANCE BR3SUT W/OC

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code MAI·January 23, 2019

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·December 1, 2010

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 11, 2013

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 3, 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