Wednesday - July 15, 2026
FDA Center for Devices & Radiological Health Issues Warning Letter to Nihon Kohden Digital Health Solutions
July 15, 2026
WASHINGTON, July 15 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Nihon Kohden Digital Health Solutions LLC from its Center for Devices and Radiological Health:

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Recipient: Harsh Dharwad, President and Chief Executive Officer, Nihon Kohden Digital Health Solutions, LLC, 14 Bunsen, Irvine, CA 92618, United States, (b)(6), (b)(7)(C)

Issuing Office: Center for Devices and Radiologic . . .

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