BEUDAMED
    4 results · 21ms · Sources: EU EUDAMED, US FDA

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    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

    Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, 10-2715-14, 10-2725-14, and 10-2755-14

    FDA Enforcement
    Class II ·Terminated·Johnson & Johnson Surgical Vision Inc·February 5, 2020

    Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL

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

    Alcon Custom Ophthalmic Surgical Procedure Packs

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LLC·April 7, 2021