BEUDAMED
    3 results · 13ms · Sources: EU EUDAMED, US FDA

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    Intelerad InteleShare software, with ProViewer component

    FDA Enforcement
    Class II ·Ongoing·DICOM Grid, Inc.·December 24, 2025

    In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;

    FDA Enforcement
    Class III ·Ongoing·Abbott Molecular, Inc.·March 6, 2024

    Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239

    FDA Enforcement
    Class I ·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025