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 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

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

Violation Codes1

ISO 13485:2016 Clause 4.1.5

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