Sigma Biomedical

Sigma Biomedical — FDA 510(k) Submissions

Sigma Biomedical has submitted 1 FDA 510(k) premarket notifications since 2025, of which 1 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Stimulator, Nerve, Transcutaneous, Over-the-counter . Use the specialty filter in the sidebar to narrow results.