BEUDAMED
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    PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TRAVERSE OCT SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ATTAIN ABILITY PLUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code OJX·June 10, 2014

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·December 10, 2012

    SENSOR ENLITE

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·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