BEUDAMED
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    INITARY BETTER BLADDER-PEDIATRIC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1430210·Rod Template, 500mm

    Critical Cover

    FDA UDI
    Alpha Pro Tech, Inc.·10817583021882·Coverall, GenPro, White, Inset Sleeve, Zip Clos...

    CERVICAL PLATE VARIABLE SELF-DRILLING SCREW DIAM. 4X16MM (2X)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWQ·November 10, 2016

    CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X14MM (2X)

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWQ·September 13, 2018

    TIGER SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604

    FDA 510(k)
    FDA Class 2 ·Immunology

    MONITOR ADAPT CABLE ICP, 5 PIN NIHON-KOHDEN

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES, LTD.·Product code GWM·May 19, 2015

    FREESTYLE PRECISION NEO

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·January 10, 2017

    MECTA C VARIABLE SELF-DRILLING SCREW DIAM. 4X18MM (2X)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWQ·June 24, 2022

    CERVICAL PLATE VARIABLE SELF-TAPPING SCREW DIAM. 4X14MM (2X)

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWQ·June 8, 2018

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 3, 2014

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 31, 2013

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    FDA Adverse Event
    Injury ·COOK, INC.·Product code MIH·June 16, 2011

    CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X18MM (2X)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWQ·September 15, 2021

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012