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

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    IL TEST 97575-15, HEPARIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology

    Legacy™3 Implant

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307102526·4.2mmD x 11.5mmL, 3.5mmD Platform

    CONCISE LIGHT CURED WHITE SEALANT

    FDA 510(k)
    FDA Class 2 ·Dental

    LEAP FROG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVIA CENTAUR CP

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·June 10, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LGW·December 10, 2012

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 23, 2015

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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