BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    LUMICELL, INC

    FDA registration
    LUMICELL, INC·1 product·🇺🇸 United States

    Lumicell Direct Visualization System (DVS)

    FDA UDI
    Lumicell, Inc.·00860003252505·Sterile Cover

    Lumicell Direct Visualization System (DVS)

    FDA UDI
    Lumicell, Inc.·00860003252567·Calibration Plate, Disposable

    Lumicell Direct Visualization System (DVS)

    FDA UDI
    Lumicell, Inc.·00860003252543·Workstation Assembly

    Lumicell Direct Visualization System (DVS)

    FDA UDI
    Lumicell, Inc.·00860003252536·Light source

    Lumicell Direct Visualization System (DVS)

    FDA UDI
    Lumicell, Inc.·00860003252550·Handheld Probe

    Lumicell Direct Visualization System (DVS)

    FDA UDI
    Lumicell, Inc.·00860008537898·Sterilization Tray

    Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Software Version: Not Applicable Product Description: Sterile Cover Component: Lumicell Direct Visualization System (DVS) / PMA # P230014

    FDA Recall
    Open, Classified ·Lumicell, Inc.·Product code SAW·July 31, 2025

    Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Software Version: Not Applicable Product Description: Sterile Cover Component: Lumicell Direct Visualization System (DVS) / PMA # P230014

    FDA Enforcement
    Class II ·Ongoing·Lumicell, Inc.·September 10, 2025