Sigma Biomedical is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Sigma Biomedical - FDA 510(k) Cleared Devices
Recent clearances: Triathlon Pro
1
Total
1
Cleared
0
Denied
Sigma Biomedical has 1 FDA 510(k) cleared medical devices. Based in Sunrise, US.
Latest FDA clearance: Nov 2025. Active since 2025. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Sigma Biomedical Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Sigma Biomedical
1 devices