BEUDAMED
    68 results · 19ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Country: Sweden ×

    is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma 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 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

    RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.

    FDA Enforcement
    Class II ·Ongoing·Cellavision AB·November 26, 2025

    Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.

    FDA Enforcement
    Class II ·Terminated·ELEKTA SOLUTIONS AB·October 20, 2021

    RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care Product name (build number): (1)RayCare 5B SP1 (5.1.1.60246); (2)RayCare 5B SP3 (5.1.3.60023); (3) RayCare 6A (6.0.0.60553)

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·November 8, 2023