BEUDAMED
    4 results · 11ms · Sources: EU EUDAMED, US FDA

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    Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 9, 2025

    Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 9, 2025

    Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vitro diagnostic chemistry analyzer.

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 9, 2025

    ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare GmbH·September 25, 2024