Company ยท IL
Augmedics, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2026. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 31, 2026 | K261854 | xvision Spine system Augmedics, Ltd., IL | SBF |
| Oct 3, 2025 | K251639 | xvision Spine system Augmedics, Ltd., IL | SBF |
| Mar 13, 2025 | K250255 | xvision Spine system Augmedics, Ltd., IL | SBF |
| Oct 16, 2024 | K241481 | xvision Spine System Augmedics, Ltd., IL | SBF |
| Nov 17, 2022 | K220905 | xvision Spine System Augmedics, Ltd., IL | SBF |
| Jul 19, 2021 | K211188 | xvision Spine system (XVS) Augmedics, Ltd., IL | SBF |
| Dec 20, 2019 | K190929 | xvision Spine system (XVS) Augmedics, Ltd., IL | SBF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2025 | Augmedics Ltd. Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle scre Open, Classified |
OLO | K211188 |