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Tempus AI, Inc. FDA Approvals

0 new drug approvals and 5 device clearances on file. Matched by name to TEM.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
Tempus ECG-MR510(k)Sep 25, 2026Cardiovascular
Tempus ECG-PH510(k)Aug 21, 2026Cardiovascular
xR IVD510(k)Sep 19, 2025Pathology
Tempus ECG-Low EF510(k)Jul 15, 2025Cardiovascular
Tempus ECG-AF510(k)Jun 21, 2024Cardiovascular

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