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

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Record Details

This FDA Inspection record concerns Helios Cardio Inc., with an inspection on March 6, 2026, issued by the New England District Office, covering medical devices & rad health.

Company: Helios Cardio Inc.
Inspection Date: March 6, 2026
Product Type: Medical Devices & Rad Health
Office: New England District Office

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ID · 1a82219f-0db8-4409-a6cf-cdc3ab0f2118

Violation Codes1

ISO 13485:2016 Clause 4.1.5

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