BEUDAMED
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    ZYNO MEDICAL ADMINISTRATION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONTIGEN COLLAGEN TREATMENT SYRINGE

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code LNM·May 16, 2013

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·September 29, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 17, 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