BEUDAMED
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    SUN MAY INDUSTRIAL CO., LTD.

    FDA registration
    SUN MAY INDUSTRIAL CO., LTD.·4 products·🇹🇼 Taiwan

    May-Grunwald' s Solution

    Device
    EU IVDR · Eu Ivd Class A ·BaSO Biotech Co., LTD..·On the market

    May-Grunwald' s Solution

    Device
    EU IVDR · Eu Ivd Class A ·BaSO Biotech Co., LTD..·On the market

    May-Grunwald's Giemsa Stain (for Autostainer)

    Device
    EU IVDR · Eu Ivd Class A ·BaSO Biotech Co., LTD..·On the market

    May-Grunwald's Giemsa Stain (for Autostainer)

    Device
    EU IVDR · Eu Ivd Class A ·BaSO Biotech Co., LTD..·On the market

    May-Grunwald's Giemsa Stain (for Autostainer)

    Device
    EU IVDR · Eu Ivd Class A ·BaSO Biotech Co., LTD..·On the market

    May-Grunwald's Giemsa Stain (for Autostainer)

    Device
    EU IVDR · Eu Ivd Class A ·BaSO Biotech Co., LTD..·On the market

    May-Grunwald's Giemsa Stain (for Autostainer)

    Device
    EU IVDR · Eu Ivd Class A ·BaSO Biotech Co., LTD..·On the market

    May-Grunwald's Giemsa Stain (for Autostainer)

    Device
    EU IVDR · Eu Ivd Class A ·BaSO Biotech Co., LTD..·On the market

    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

    DAY SUN TECHNOLOGY LIMITED

    FDA registration
    DAY SUN TECHNOLOGY LIMITED·5 products·🇹🇼 Taiwan

    CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)

    FDA Enforcement
    Class II ·Ongoing·Kung Shin Plastics Co. Ltd.·March 12, 2025

    CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)

    FDA Enforcement
    Class II ·Ongoing·Kung Shin Plastics Co. Ltd.·March 12, 2025

    Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.

    FDA Enforcement
    Class II ·Terminated·EMG Technology Co., Ltd.·September 24, 2014

    UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.

    FDA Enforcement
    Class II ·Terminated·United Orthopedic Corporation·April 5, 2017

    DAY SUN INDUSTRIAL CORP

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE11151217 - 17x150mm, PE11151411 - 11x200mm, PE11151413 - 13x200mm, PE11151415 - 15x200mm, PE11151417 - 17x200mm,

    FDA Enforcement
    Class II ·Ongoing·United Orthopedic Corporation·March 6, 2024

    USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE25153115 - 15x125mm, PE25153211 - 11x150mm, PE25153213 - 13x150mm, PE25153217 - 17x150mm, PE25153117 - 17x125mm, PE25153015 - 15x100mm, PE25153215 - 15x150mm

    FDA Enforcement
    Class II ·Ongoing·United Orthopedic Corporation·March 6, 2024

    USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE25151117 - 17X125mm, PE25151119 - 19X125mm, PE25151209 - 9X150mm, PE25151211 - 11X150, PE25151213 - 13X150mm, PE25151215 - 15X150mm, PE25151217 - 17X150mm, PE25151415 - 15x200mm

    FDA Enforcement
    Class II ·Ongoing·United Orthopedic Corporation·March 6, 2024