Biozen, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Biozen, LLC - FDA 510(k) Cleared Devices
Recent clearances: BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)
1
Total
1
Cleared
0
Denied
Biozen, LLC has 1 FDA 510(k) cleared medical devices. Based in Oklahoma City, US.
Latest FDA clearance: May 2026. Active since 2026. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Biozen, LLC Filter by specialty or product code using the sidebar.
1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Biozen, LLC
1 devices