BEUDAMED
    2 results · 24ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.

    FDA Enforcement
    Class II ·Terminated·Clarity Medical Systems Inc·March 19, 2014

    Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.

    FDA Enforcement
    Class II ·Terminated·Clarity Medical Systems Inc·March 26, 2014