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

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    AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Kit Boxes and Kit Plates

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Whitebox Large box

    Device
    EU MDR · Eu Md Class 1 ·WhiteBox AB·On the market·20 countries

    Effort Belt Communication Box

    Device
    EU MDR · Eu Md Class 1 ·Breas Medical AB·On the market·19 countries

    Dual limb pediatric 10pc/box

    Device
    EU MDD · Eu Md Class 2a ·Breas Medical AB·On the market·21 countries

    Dual limb adult 10pc/box

    Device
    EU MDD · Eu Md Class 2a ·Breas Medical AB·On the market·21 countries

    Accessory Box Vivo 1-2-3

    Device
    EU MDR · Eu Md Class 1 ·Breas Medical AB·On the market·17 countries

    Dual limb Insert Pediatric - 10pc/box (005525)

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Breas Medical AB·1 device

    Dual limb Insert adult - 10pc/box (005523)

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Breas Medical AB·1 device

    DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.

    FDA Enforcement
    Class III ·Terminated·Euro Diagnostica AB·July 5, 2017

    Circuit: Single Limb 15mm x 1.8m Disposable 30pcs/box (006712)

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Breas Medical AB·1 device

    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

    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

    The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.112 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. The box contains 4 vials with 25 microcuvettes in each vial.

    FDA Enforcement
    Class II ·Ongoing·HemoCue AB·July 9, 2025

    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

    RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICATION NAME: System, Planning, Radiation Therapy Treatment. RayStation is a software system designed for treatment planning and analysis of radiation therapy.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 5, 2013

    The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. 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·September 26, 2012