BEUDAMED
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    ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ASANTE SNAP INSULIN PUMP SYSTEM

    FDA Adverse Event
    Injury ·ASANTE SOLUTIONS INC.·Product code LZG·August 11, 2014

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05056139243615·UNITY KNEE™ PS-C INSERT - Size 8T-7F x 22mm

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564031372·Basic Pack

    SYNTHES 3.5 MM BROAD LC-DCP PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSBONE DENTAL

    FDA 510(k)
    FDA Class 2 ·Dental

    ASCENDRA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code NPT·May 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 11, 2011

    GALEO F 14

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO·Product code DQX·August 15, 2008

    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