Infinium Medical, Inc. is one of 12995 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Infinium Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Vital Signs Monitor (CLEO2)
1
Total
1
Cleared
0
Denied
Infinium Medical, Inc. has 1 FDA 510(k) cleared medical devices. Based in Largo, US.
Latest FDA clearance: Aug 2026. Active since 2026. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Infinium Medical, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Shanghai SUNGO Management Consulting Co., Ltd. as regulatory consultant.
FDA 510(k) Regulatory Record - Infinium Medical, Inc.
1 devices