Smart Reactors is one of 55 FDA 510(k) medical device manufacturers from Ireland in the dataset, ranked by real submission volume.
Smart Reactors - FDA 510(k) Cleared Devices
Recent clearances: Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)
1
Total
1
Cleared
0
Denied
Smart Reactors has 1 FDA 510(k) cleared medical devices. Based in Galway, IE.
Latest FDA clearance: Feb 2026. Active since 2026. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Smart Reactors Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Psephos Biomedica as regulatory consultant.
FDA 510(k) Regulatory Record - Smart Reactors
1 devices