FDA Inspection 1305774 - Helios Cardio Inc. - March 06, 2026

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Helios Cardio Inc.

Record Details

This FDA Inspection record concerns Helios Cardio Inc., with an inspection on March 6, 2026, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.

Company: Helios Cardio Inc.
Inspection Date: March 6, 2026
Product Type: Medical Devices & Rad Health
Office: Center for Devices and Radiological Health

Open in Dashboard

ID · 203a31e4-8d67-4688-a6d6-80b0b7b09c55

Violation Codes1

ISO 13485:2016 Clause 4.1.5

Full citation text and observation details available on the Dashboard.