BEUDAMED
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    mcompass Biofeedback Anorectal Manometry System

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

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707011897·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 31

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1430210·Rod Template, 500mm

    4.3MHZ PENCIL PROBE 7'

    FDA UDI
    PARKS MEDICAL ELECTRONICS, INC.·00816787020663·

    BMR FACE

    FDA 510(k)
    FDA Class 2 ·Neurology

    SERIM DIALYSATE MONITOR TEST STRIP

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

    GORE TAG THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·May 23, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·September 27, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·June 23, 2011

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015