BEUDAMED
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    AGAMATRIX HEALTH MANAGER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180166271·3 Fr. (1.0 mm), 28cm, Biopsy Cup Forceps , Flex...

    HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DISCOVRED

    FDA 510(k)
    FDA Class 2 ·Dental

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·October 1, 2014

    HYDRATOME? RX 44

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNS·May 29, 2013

    STERRAD 100NX STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·June 17, 2011

    HLM TUBING SET W/SOFTLINE COATING

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·November 18, 2015

    HLM TUBING SET W/SOFTLINE COATING

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·June 3, 2016

    HLM TUBING SET W/BIOLINE COATING

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·August 2, 2016

    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