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

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    THERMAPOST ENDODONTIC ROOT CANAL POST

    FDA 510(k)
    FDA Class 1 ·Dental

    HYALURONIDASE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    S-LOK PSS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BARDIA FOLEY CATHETER SILICONE COATED K922431

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON) -1018233·Product code KOD·November 1, 2021

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 18, 2013

    REVEAL XT

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DSI·December 13, 2010

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·LIVANOVA USA, INC.·Product code LYJ·July 9, 2014

    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