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Tempus AI, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K241868xR IVDSeptember 19, 2025
K250119Tempus ECG-Low EFJuly 15, 2025
K233549Tempus ECG-AFJune 21, 2024