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

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    Device
    EU MDR · Eu Md Class 2a ·SBO Hearing A/S·On the market·27 countries

    PROTECTION DRAPES AND GARMENTS - OTHER

    Device
    EU MDR · Eu Md Class 1 ·Borch Textile Group A/S·On the market·4 countries

    SigmaTech Nordic ApS

    Authorized representative
    🇩🇰 Denmark·5 Manufacturers·311 Devices

    Neria Soft Infusion Set, Product Code 507302, intravascular administration set

    FDA Enforcement
    Class II ·Ongoing·Unomedical A/S·April 24, 2024

    VariSoft Infusion Set, Single Use.

    FDA Enforcement
    Class II ·Ongoing·Unomedical A/S·September 25, 2024

    The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath through which a rotatable radiopaque spiral shaft extends ending in an eccentric blunt distal tip. Once activated, the shaft rotates at approximately 10.000 RPMs to break thrombus into smaller particles, which can be simultaneously aspirated using a dedicated vacuum syringe. The catheter is a stand-alone system and is powered by a 4.5 VDC alkaline battery pack in the control unit.

    FDA Enforcement
    Class II ·Ongoing·Mermaid Medical A/S·July 3, 2024

    AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.

    FDA Enforcement
    Class II ·Ongoing·Radiometer Medical ApS·April 26, 2023

    Cephalon Finland A/S

    Importer
    🇩🇰 Denmark·16 Manufacturers

    Cephalon A/S

    Importer
    🇩🇰 Denmark·17 Manufacturers

    ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) " In vitro testing of samples of expired air for the parameters pO2 and pCO2 " In vitro testing of pleura samples for the pH parameter.

    FDA Enforcement
    Class II ·Ongoing·Radiometer Medical ApS·July 31, 2024