BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    Bernafon

    FDA UDI
    Bernafon AG·05711584053072·JU7 ITEPD, WL R BE JUNA 7

    RELINE-IT MODEL RELINE-IT

    FDA 510(k)
    FDA Class 2 ·Dental

    TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    PERSONA TRABECULAR METAL 2 PEG TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code MBH·August 29, 2016

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 4, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 27, 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