BEUDAMED
    16 results · 25ms · 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: Denmark ×

    Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.

    FDA Enforcement
    Class II ·Terminated·Unomedical A/S·October 5, 2022

    EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.

    FDA Enforcement
    Class II ·Terminated·Dako Denmark A/S·August 10, 2016

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

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

    safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·June 10, 2020

    safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·June 10, 2020

    safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·June 10, 2020

    VariSoft Infusion Set, Single Use.

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

    Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE

    FDA Enforcement
    Class II ·Ongoing·Radiometer Medical ApS·May 25, 2022

    ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·July 8, 2020

    ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·July 8, 2020

    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable

    FDA Enforcement
    Class II ·Ongoing·Agilent Technologies Denmark ApS·September 24, 2025

    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable

    FDA Enforcement
    Class II ·Ongoing·Agilent Technologies Denmark ApS·September 24, 2025

    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable

    FDA Enforcement
    Class II ·Ongoing·Agilent Technologies Denmark ApS·September 24, 2025

    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

    Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument.

    FDA Enforcement
    Class II ·Terminated·Mermaid Medical A/S·July 29, 2015

    Triolab AS

    Importer
    🇩🇰 Denmark·11 Manufacturers