2 results
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30ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras.
FDA Recall
Terminated
·Kowa Optimed Inc·Product code NFJ·November 3, 2020
Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras.
FDA Enforcement
Class II
·Terminated·Kowa Optimed Inc·December 23, 2020