BEUDAMED
    3 results · 19ms · Sources: EU EUDAMED, US FDA

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    Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·December 17, 2025

    Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V

    FDA Enforcement
    Class II ·Terminated·Sonesta Medical Ab·May 10, 2017

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021