Company
United StatesNihon Kohden Digital Health Solutions, Inc., Irvine, CA – FDA Inspections
Inspection records and compliance data for Nihon Kohden Digital Health Solutions, Inc. in Irvine, California. 4 FDA inspections on record, 1 warning letter, last inspected February 24, 2026.
Company Profile
This profile covers Nihon Kohden Digital Health Solutions, Inc. based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 0
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 1
First inspected August 5, 2011. Last inspected February 24, 2026.
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 24, 2026 | Not classified | Medical Devices & Rad Health | 1306654 |
| June 13, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1208893 |
| May 13, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 974339 |
| August 5, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 740018 |
FDA documents
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Nihon Kohden Digital Health Solutions, Inc.
FEI Number
3003142870
Address
14 Bunsen, Irvine, California 92618, United States
Country
United States
ID: cb3d5580-cb8f-45e9-a2b3-59fc7469e7cc