Biotracker, LLC is one of 16347 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Biotracker, LLC - FDA 510(k) Cleared Devices
Recent clearances: BioTracker 2.0
1
Total
1
Cleared
0
Denied
Biotracker, LLC has 1 FDA 510(k) cleared medical devices. Based in Miami, US.
Latest FDA clearance: Jun 2026. Active since 2026. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Biotracker, LLC Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Sigma Biomedical as regulatory consultant.
FDA 510(k) Regulatory Record - Biotracker, LLC
1 devices