Helios Biomedical, Inc.

Helios Biomedical, Inc. — FDA 510(k) Submissions

Helios Biomedical, Inc. has submitted 2 FDA 510(k) premarket notifications since 2025, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Wound Dressing With Animal-derived Material(s), Dura Substitute . Use the specialty filter in the sidebar to narrow results.