BEUDAMED
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    Atlas

    FDA UDI
    Eyoto, Inc.·05070000542829·Automated AC powered Ophthalmic Lens Analyser f...

    Atlas

    FDA UDI
    Eyoto, Inc.·05070000542836·Automated AC powered lensmeter for the verficat...

    SHOFU PRODUCTS KYOTO INC.

    FDA registration
    SHOFU PRODUCTS KYOTO INC.·3 products·🇯🇵 Japan

    Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.

    FDA Enforcement
    Class I ·Terminated·C.L.R. Medicals International, Inc.·January 1, 2014

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·December 21, 2021

    Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.

    FDA Recall
    Terminated ·C.L.R. Medicals International, Inc.·Product code LZP·November 25, 2013