Helios Biomedical, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Helios Biomedical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Helios Dermal Scaffold, Helios Dura Regeneration Matrix
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