BEUDAMED
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    Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube.

    FDA Enforcement
    Class I ·Ongoing·Elekta Instrument AB·April 24, 2024

    Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to mount without the need for any tools. It fits both floor and wall mounted toilets. If space around the toilet is limited either armrest can easily be detached. Supporter includes seat ring and lid.

    FDA Enforcement
    Class II ·Terminated·Etac Supply Center Ab·July 22, 2015

    Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat designed as a seating and standing support for personal hygiene purposes for people with reduced mobility. The Etac Relax shower seat is used for sitting where space is restricted, and can be folded up when not in use. Etac Relax is intended for home use.

    FDA Enforcement
    Class II ·Terminated·Etac Supply Center Ab·August 19, 2015

    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

    Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube. The system is used for for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.

    FDA Enforcement
    Class I ·Ongoing·Elekta Instrument AB·November 13, 2024

    RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·April 9, 2014

    RayStation 9B SP1. For radiation treatment planning.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·July 27, 2022

    RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·April 21, 2021

    RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·April 30, 2014

    EVA Floor Lifts, Model Numbers: 400, 450, 600

    FDA Enforcement
    Class II ·Ongoing·Handicare AB·May 20, 2020

    Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

    FDA Enforcement
    Class III ·Terminated·Getinge Disinfection Ab·August 26, 2015

    Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.

    FDA Enforcement
    Class II ·Terminated·Euro Diagnostica AB·January 10, 2018

    RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system

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

    RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 25, 2014

    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

    HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden

    FDA Enforcement
    Class II ·Terminated·HemoCue AB·November 6, 2013

    RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose distributions.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·July 27, 2016

    1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia.

    FDA Enforcement
    Class II ·Terminated·AB ULAX·October 14, 2020

    RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·April 17, 2024

    SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·October 3, 2012