Company
United StatesCardionxt, Denver, CO – FDA Inspections
Inspection records and compliance data for Cardionxt in Denver, CO. 1 FDA inspection on record, 1 Form 483, last inspected December 15, 2025.
Company Profile
This profile covers Cardionxt based in Denver, CO, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected December 15, 2025.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Devices subject to device identification GUDID data submission requirements.1 inspection
- Investigation of device failures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 15, 2025 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1295340 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Cardionxt
FEI Number
3020036682
Address
12011 Tejon St Ste 700, Denver, CO 80234-2313, United States
Country
United States
ID: 4a1899d9-92e4-497d-8ffb-79f1edfe1423