FDA Inspection 1312460 - EVOLUTION DEVICES, INC - April 15, 2026

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Record Details

This FDA Inspection record concerns EVOLUTION DEVICES, INC, with an inspection on April 15, 2026, issued by the Center for Devices and Radiological Health, covering devices.

Company: EVOLUTION DEVICES, INC
Inspection Date: April 15, 2026
Product Type: Devices
Office: Center for Devices and Radiological Health

Open in Dashboard

ID · b09a8674-248b-4e79-9d34-2c920197904b

Violation Codes6

ISO 13485:2016 Clause 5.6.1ISO 13485:2016 Clause 7.1ISO 13485:2016 Clause 7.4.1ISO 13485:2016 Clause 7.5.8ISO 13485:2016 Clause 8.2.4ISO 13485:2016 Clause 8.5.2

Full citation text and observation details available on the Dashboard.