FDA Inspection
CardionxtCardionxt – FDA Inspection, Dec 15, 2025
Record Details
This FDA Inspection record concerns Cardionxt, with an inspection on December 15, 2025, issued by the Denver District Office, covering medical devices & rad health.
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ID · a5c6447a-a319-4cf7-9ac5-148484155a66
Inspection Facts
- Inspection number
- 1295340
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
6- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
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