Brainlab SE

FDA Regulatory Profile

Brainlab SE appears in FDA public data with 0 recalls, 1 510(k) clearance, 4 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on January 14, 2026.

Summary

Total Recalls
0
510(k) Clearances
1
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K254010ExacTrac Dynamic (2.0.2); ExacTrac Dynamic SurfaceJanuary 14, 2026