Gauthier Biomedical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
1
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0572-2025Class IITriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)November 11, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K180092IntellitorqMarch 8, 2018