Gauthier Biomedical, Inc.
FDA Regulatory Profile
Gauthier Biomedical, Inc. appears in FDA public data with 1 recall, 1 510(k) clearance, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0572-2025, Class II) was initiated on November 11, 2024. Its most recent 510(k) clearance was granted on March 8, 2018.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0572-2025 | Class II | TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509) | November 11, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K180092 | Intellitorq | March 8, 2018 |