BEUDAMED
    3 results · 28ms · Sources: EU EUDAMED, US FDA

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    Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS

    FDA Enforcement
    Class II ·Ongoing·Covidien, LP·April 10, 2024

    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

    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