BEUDAMED
    3 results · 16ms · Sources: EU EUDAMED, US FDA

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    COOL EYE(TM) EYE PROTECTOR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6

    FDA 510(k)
    FDA Class 2 ·Neurology

    Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief¿ products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.

    FDA Enforcement
    Class II ·Terminated·O-Two Medical Technologies, Inc.·July 19, 2017