Nihon Kohden Digital Health Solutions, LLC: FDA Warning Letter, Jun 12, 2026

Status: Unknown as of Oct 16, 2026. Warning letters are informal and advisory, not final agency action. Original on FDA.gov.

Company
Nihon Kohden Digital Health Solutions, LLC (as published by FDA)
Letter date
Jun 12, 2026
Posted
Jul 14, 2026
Office
Center for Devices and Radiological Health
Subject
“Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)”
Response
None posted by FDA as of last check
Close-out
None posted by FDA as of last check
Source
FDA.gov · retrieved Oct 16, 2026

Get new FDA warning letters by email. One digest a week, free.

Double opt-in: we email you a link to confirm. One-click unsubscribe in every email. You must be at least 18. See our Privacy policy.

Need it same day for your suppliers? Reserve a founding Pro seat.

Topics: Medical devices

Text above is quoted or paraphrased from FDA.

Something wrong or out of date? Request a correction. We review correction requests within 5 business days.

← All letters