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Helios Biomedical, Inc. FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
Helios Dermal Scaffold510(k)Aug 15, 2025
Helios Dura Regeneration Matrix510(k)May 14, 2025Neurology

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