BEUDAMED
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    LSP MINILATOR

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707032632·WEB 1ST MOLAR BANDS n.LR 16

    ELLIPSE 12PL, MODEL 9ESL7228

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPRINT QUATTRO SECURE

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

    UNKNOWN

    FDA Adverse Event
    Injury ·HISTORICAL CPI ST. PAUL·Product code LWS·October 7, 2010

    ZELTIQ COOLMAX APP (8.0)

    FDA Adverse Event
    Injury ·ZELTIQ AESTHETICS INC.·Product code OOK·December 5, 2012

    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