BEUDAMED
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    KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VERESURE BELL

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

    Mont Blanc and Mont Blanc MIS Spinal Systems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPRINT QUATTRO SECURE S MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 10, 2014

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·October 8, 2010

    1020279-2012-00664

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·December 7, 2012

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012