BEUDAMED
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    CYTOLOGY BRUSHES

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

    KONAN CLINIC MICROSCOPE CLM-100-150

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    POTATO DEXTROSE AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·June 10, 2014

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 7, 2010

    IFUSE IMPLANT SYSTEM

    FDA Adverse Event
    Other ·SIBONE INC.·Product code OUR·December 6, 2012

    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

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015