Koios Medical, Inc. is one of 16117 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Koios Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Koios DS (3.8), Koios DS, Koios DS
4
Total
4
Cleared
0
Denied
Koios Medical, Inc. has 4 FDA 510(k) cleared medical devices. Based in New York, US.
Latest FDA clearance: Jul 2026. Active since 2019. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Koios Medical, Inc. 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 - Koios Medical, Inc.
4 devices