Augmedics Ltd.
FDA Regulatory Profile
Augmedics Ltd. appears in FDA public data with 1 recall, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1761-2025, Class II) was initiated on April 14, 2025. Its most recent 510(k) clearance was granted on October 3, 2025.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1761-2025 | Class II | Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) s | April 14, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251639 | xvision Spine system | October 3, 2025 |
| K250255 | xvision Spine system | March 13, 2025 |
| K241481 | xvision Spine System | October 16, 2024 |
| K220905 | xvision Spine System | November 17, 2022 |
| K211188 | xvision Spine system (XVS) | July 19, 2021 |
| K190929 | xvision Spine system (XVS) | December 20, 2019 |