Tempus AI, Inc. is one of 16115 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Tempus AI, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Tempus ECG-MR, Tempus ECG-PH, xR IVD
5
Total
5
Cleared
0
Denied
Tempus AI, Inc. has 5 FDA 510(k) cleared medical devices. Based in Chicago, US.
Latest FDA clearance: Sep 2026. Active since 2024. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Tempus AI, Inc. Filter by specialty or product code using the sidebar.
2 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Tempus AI, Inc.
5 devices