BEUDAMED
    10 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    VACUETTE SAFELINK, REF: 450210

    FDA Enforcement
    Class II ·Ongoing·Greiner Bio-One GmbH·January 15, 2025

    On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33

    FDA Enforcement
    Class II ·Ongoing·On-X Life Technologies, Inc.·May 20, 2026

    Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.

    FDA Enforcement
    Class II ·Ongoing·Biocartis Nv·January 22, 2025

    Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A

    FDA Enforcement
    Class II ·Ongoing·BARCO NV·October 5, 2022

    VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.

    FDA Enforcement
    Class II ·Ongoing·Greiner Bio-One North America, Inc.·January 24, 2024

    VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged

    FDA Enforcement
    Class II ·Ongoing·Greiner Bio-One North America, Inc.·July 24, 2024

    Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322

    FDA Enforcement
    Class II ·Ongoing·Greiner Bio-One North America, Inc.·November 5, 2025

    Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)

    FDA Enforcement
    Class II ·Ongoing·Greiner Bio-One North America, Inc.·November 26, 2025

    Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000 (including all SU s and HF s)

    FDA Enforcement
    Class II ·Ongoing·Agfa Healthcare NV·October 16, 2024

    Agfa HealthCare Enterprise Imaging XERO Viewer

    FDA Enforcement
    Class II ·Ongoing·Agfa Healthcare NV·February 1, 2023