Bioventus, LLC is one of 16105 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Bioventus, LLC - FDA 510(k) Cleared Devices
Recent clearances: StimTrial Neuromodulation System, StimTrial Neuromodulation System, TalisMann Neuromodulation System
6
Total
6
Cleared
0
Denied
Bioventus, LLC has 6 FDA 510(k) cleared medical devices. Based in Durham, US.
Latest FDA clearance: Aug 2026. Active since 2017. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Bioventus, LLC Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Bruder Consulting & Venture Group as regulatory consultant.
FDA 510(k) Regulatory Record - Bioventus, LLC
6 devices
Cleared
Aug 26, 2026
StimTrial Neuromodulation System
Neurology
265d
Cleared
Jul 16, 2025
StimTrial Neuromodulation System
Neurology
219d
Cleared
Jul 03, 2025
TalisMann Neuromodulation System
Neurology
218d
Cleared
Jun 25, 2024
Allograft Delivery Device (OFAC-C)
General & Plastic Surgery
267d
Cleared
Dec 05, 2023
SIGNAFUSE Bioactive Strip (SBS)
Orthopedic
39d
Cleared
Feb 13, 2017
MCS Bone Graft
Orthopedic
124d