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

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    Filters Classification: Class Ii ×

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·July 24, 2024