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

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    Filters Classification: Class Ii ×

    TriFoillmaging Triumph/Triumph II Research CT scanners.

    FDA Enforcement
    Class II ·Terminated·Northridge Tri-Modality Imaging,·October 12, 2016

    Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·July 16, 2025