BEUDAMED
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    MAJOR BASIN TRAY

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·34546540244322·BONE SCREWS, CROSS-FIT, SELF-TAPPING

    Malibu

    FDA UDI
    Seaspine Orthopedics Corporation·10889981080518·Bone Probe, Extended Straight

    McKesson

    FDA UDI
    MCKESSON MEDICAL-SURGICAL INC.·20612479265794·Procedure Face Masks

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123069·K-WIRE - DOUBLE TROCAR 1.0mm DIA x 100mm

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756021166·FINGER SPLINTS

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867057449·UNIVERSAL GLENOID - INLAY SMALL PLUS

    ELECSYS N-MID OSTEOCALCIN CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ECC PACK W/PEDIATRIC QUADROX ID

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DWE·May 13, 2014

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code LEH·January 11, 2013

    CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code KRH·December 1, 2010

    PLEURX DRAINAGE KIT 1000ML - 50-7510

    FDA Adverse Event
    Malfunction ·Product code DWM·June 7, 2021

    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