FDA action counts
| Total FDA actions | 1 |
|---|---|
| Warning letters | 1 |
| Recalls | 0 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | June 12, 2026 |
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. Nihon Kohden Digital Health Solutions, LLC has 1 FDA event on file. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
Enforcement history
On 2026-06-12, Argus HQ recorded an FDA Warning Letter for Nihon Kohden Digital Health Solutions, LLC, rated "critical" severity in Argus HQ's classification: Nihon Kohden Digital Health Solutions, LLC — Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) (2026-06-12). Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.
Frequently asked questions
- What is the most recent FDA action against Nihon Kohden Digital Health Solutions, LLC?
- The most recent FDA event Argus HQ has on file for Nihon Kohden Digital Health Solutions, LLC is dated 2026-06-12, with a severity rating of "critical" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
- Does Argus HQ track new FDA actions for Nihon Kohden Digital Health Solutions, LLC automatically?
- Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Nihon Kohden Digital Health Solutions, LLC is observed, this page's event count and history update automatically.
- How many FDA actions does Argus HQ track for Nihon Kohden Digital Health Solutions, LLC?
- 1 total: 1 warning letter, 0 recalls, 0 approval records, and 0 Form 483 inspection citations.
- What is the most recent FDA action on file for Nihon Kohden Digital Health Solutions, LLC?
- June 12, 2026. Argus HQ ingests new FDA enforcement records daily.
Every FDA action tied to this company, the week it happens.
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Related enforcement actions
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Two different companies merged onto this page by mistake? Or a name variant missing? Tell us — corrections@argushq.ai
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Verified from FDA.gov · Last updated: Jun 12, 2026Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Enforcement History: Nihon Kohden Digital Health Solutions, LLC. Digital Empire LLC. Retrieved from https://argushq.ai/company/nihon-kohden-digital-health-solutions-llc
"FDA Enforcement History: Nihon Kohden Digital Health Solutions, LLC." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/nihon-kohden-digital-health-solutions-llc.
Argus HQ Research. "FDA Enforcement History: Nihon Kohden Digital Health Solutions, LLC." Digital Empire LLC. Accessed July 16, 2026. https://argushq.ai/company/nihon-kohden-digital-health-solutions-llc.
@misc{argushq_argushq_ai_company_nihon_kohden_digital_health_solutions_llc_2026,
title = {FDA Enforcement History: Nihon Kohden Digital Health Solutions, LLC},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/company/nihon-kohden-digital-health-solutions-llc},
note = {Accessed: July 16, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗