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FDA WARNING LETTER14 July 2026

Nihon Kohden Digital Health Solutions, LLC — FDA Warning Letter

Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)

Company
Nihon Kohden Digital Health Solutions, LLC
Letter date
14 July 2026
Issuing office
Center for Devices and Radiological Health
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Warning-letter details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.