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

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    DT Controlled Phototherapy Equipment

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER

    FDA 510(k)
    FDA Class 2 ·Immunology

    RESTORIS POROUS PARTIAL KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·November 6, 2014

    IMPLANTED PICC

    FDA Adverse Event
    Injury ·C. R. BARD INC. (BASD)·Product code LJS·July 15, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 18, 2015

    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