BEUDAMED
    26 results · 8ms · Sources: EU EUDAMED, US FDA

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    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

    RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·May 26, 2021

    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