BEUDAMED
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    U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.

    FDA Enforcement
    Class II ·Terminated·United Orthopedic Corporation·March 28, 2018

    U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.

    FDA Enforcement
    Class II ·Terminated·United Orthopedic Corporation·March 28, 2018

    Create Biotech Co., Ltd.

    Manufacturer
    🇹🇼 Taiwan·1 Importer

    Soteria Biotech Co., Ltd.

    Manufacturer
    🇹🇼 Taiwan·1 Basic UDI-DI·1 Device·TÜV SÜD Product Service GmbH

    Skyla Corporation Hsinchu Science Park Branch

    Manufacturer
    🇹🇼 Taiwan·2 Basic UDI-DIs·2 Devices·5 Importers

    Radiant Innovation Inc.

    Manufacturer
    🇹🇼 Taiwan·19 Basic UDI-DIs·47 Devices·1 Importer·SGS Belgium NV and SGS Belgium NV

    I-Ming Sanitary Materials Co.,Ltd

    Manufacturer
    🇹🇼 Taiwan·10 Basic UDI-DIs·82 Devices

    Bioptik Technology, Inc.

    Manufacturer
    🇹🇼 Taiwan

    Conwell Medical Co., Ltd.

    Manufacturer
    🇹🇼 Taiwan

    Welsheng Corp.

    Manufacturer
    🇹🇼 Taiwan·7 Basic UDI-DIs·1825 Devices

    General Biologicals Corporation

    Manufacturer
    🇹🇼 Taiwan·13 Basic UDI-DIs·13 Devices·DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.

    Broadsound Corporation

    Manufacturer
    🇹🇼 Taiwan·26 Basic UDI-DIs·26 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

    Maxigen Biotech Inc.

    Manufacturer
    🇹🇼 Taiwan

    OPPO Medical Corp.

    Manufacturer
    🇹🇼 Taiwan·12 Basic UDI-DIs·1782 Devices

    Industrial technology research institute

    Manufacturer
    🇹🇼 Taiwan

    Winnomed Company Ltd.

    Manufacturer
    🇹🇼 Taiwan·3 Basic UDI-DIs·23 Devices

    GrowTrend Biomedical Co., Ltd

    Manufacturer
    🇹🇼 Taiwan

    K-jump Health Co., Ltd.

    Manufacturer
    🇹🇼 Taiwan·11 Basic UDI-DIs·11 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

    Arm Sling

    Device
    EU MDR · Eu Md Class 1 ·Welsheng Corp.·On the market

    GP3S

    Device
    EU MDD · Eu Md Class 2a ·Broadsound Corporation·On the market·1 country