Medical Device Manufacturer · US , Weston , MA

Helios Biomedical, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2025
2
Total
2
Cleared
0
Denied

Helios Biomedical, Inc. has 2 FDA 510(k) cleared medical devices. Based in Weston, US.

Latest FDA clearance: Aug 2025. Active since 2025. Primary specialty: Neurology.

Browse the FDA 510(k) cleared devices submitted by Helios Biomedical, Inc. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by QUARAS, LLC as regulatory consultant.

FDA 510(k) Regulatory Record - Helios Biomedical, Inc.
2 devices
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