Koru Medical Systems, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Koru Medical Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: FreedomEdge Infusion System
1
Total
1
Cleared
0
Denied
Koru Medical Systems, Inc. has 1 FDA 510(k) cleared medical devices. Based in Mahwah, US.
Latest FDA clearance: Jan 2026. Active since 2026. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Koru Medical Systems, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Koru Medical Systems, Inc.
1 devices