Neuraxis is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Neuraxis - FDA 510(k) Cleared Devices
Recent clearances: NeurAxis IB-Stim (01-1020), NeurAxis IB-Stim (01-1020), NeurAxis IB-Stim (01-1020)
3
Total
3
Cleared
0
Denied
Neuraxis has 3 FDA 510(k) cleared medical devices. Based in Carmel, US.
Latest FDA clearance: Oct 2025. Active since 2024. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Neuraxis Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by MRC Global, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Neuraxis
3 devices