BEUDAMED
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    RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·July 1, 2020

    is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sj¿gren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.

    FDA Enforcement
    Class III ·Terminated·Euro Diagnostica AB·August 29, 2018

    is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess of anti-cardiolipin IgG autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders

    FDA Enforcement
    Class III ·Terminated·Euro Diagnostica AB·August 29, 2018

    is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess anti-cardiolipin IgM autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders.

    FDA Enforcement
    Class III ·Terminated·Euro Diagnostica AB·August 29, 2018

    The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking precision, efficiency, and reliability in their layout tasks. The integrated Class 2 green aiming laser system enhances visibility and accuracy, even on uneven surfaces. It is ideal for general and specialty contractors, the RTS873 streamlines layout processes, reduces rework, and enhances overall productivity.

    FDA Enforcement
    Class II ·Ongoing·Trimble Ab·May 7, 2025

    Etac¿ Ono Walker, Etac¿ Avant Walker, and Etac¿ Salsa Walker. These products are four-wheeled walkers intended as a walking aid for indoor and outdoor use for persons weighing up to 125 KG.

    FDA Enforcement
    Class II ·Terminated·Etac Supply Center Ab·July 25, 2012

    Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0, 12.1.0, 12.1.1, 12.0.3, 12.1.2, 12.0.4, 12.1.3, 13.0.0, 13.1.0. Software Version Numbers 9A, 9B, 10A, 10B, 11A, 11B and 12A including service packs

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·March 29, 2023

    RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A) Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·July 25, 2018

    Bohus BioTech AB

    Manufacturer
    🇸🇪 Sweden·30 Basic UDI-DIs·30 Devices·MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, and MDC MEDICAL DEVICE CERTIFICATION GMBH

    Nidacon International AB

    Manufacturer
    🇸🇪 Sweden·15 Basic UDI-DIs·15 Devices·DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, and DNV Product Assurance AS

    Magle Chemoswed AB

    Manufacturer
    🇸🇪 Sweden·4 Basic UDI-DIs·4 Devices·CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft., CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft., CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft., and CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.

    Evolan Pharma AB

    Manufacturer
    🇸🇪 Sweden·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

    Rolf Kullgren AB

    Manufacturer
    🇸🇪 Sweden·2 Basic UDI-DIs·2 Devices·DEKRA Certification B.V. and DEKRA Certification B.V.

    Coala Life AB

    Manufacturer
    🇸🇪 Sweden·4 Basic UDI-DIs·4 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

    Aktiebolaget Ulax

    Manufacturer
    🇸🇪 Sweden·12 Basic UDI-DIs·12 Devices·RISE Research Institutes of Sweden AB and RISE Research Institutes of Sweden AB

    Nordberg Medical AB

    Manufacturer
    🇸🇪 Sweden·1 Basic UDI-DI·1 Device·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY

    Medviso AB

    Manufacturer
    🇸🇪 Sweden·5 Basic UDI-DIs·5 Devices·INTERTEK SEMKO AB

    RLS Global AB

    Manufacturer
    🇸🇪 Sweden·1 Basic UDI-DI·1 Device·Eurofins Product Testing Italy S.r.l.

    Enzymatica AB

    Manufacturer
    🇸🇪 Sweden·1 Basic UDI-DI·1 Device·Eurofins Product Testing Italy S.r.l.

    Bioglan AB

    Manufacturer
    🇸🇪 Sweden·3 Basic UDI-DIs·3 Devices·BSI Group The Netherlands B.V.