Augmedics, Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Augmedics, Ltd.” (first 2019, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 127 days. Since 2017 the median was 127 days, against 111 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 255 |
| 2020 | 0 | — |
| 2021 | 1 | 90 |
| 2022 | 1 | 234 |
| 2023 | 0 | — |
| 2024 | 1 | 145 |
| 2025 | 2 | 86 |
| 2026 | 1 | 58 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Augmedics, Ltd. took a median 127 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 111 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SBF | Orthopedic Augmented Reality | 7 | 7 |
Review panels
- Orthopedic (7)
Most recent Augmedics, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261854 | xvision Spine system | SBF | 2026-07-31 | 58 |
| K251639 | xvision Spine system | SBF | 2025-10-03 | 127 |
| K250255 | xvision Spine system | SBF | 2025-03-13 | 44 |
| K241481 | xvision Spine System | SBF | 2024-10-16 | 145 |
| K220905 | xvision Spine System | SBF | 2022-11-17 | 234 |
| K211188 | xvision Spine system (XVS) | SBF | 2021-07-19 | 90 |
| K190929 | xvision Spine system (XVS) | SBF | 2019-12-20 | 255 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2025-04-14.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Augmedics, Ltd. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04682418: Pedicle Screw Placement With XVS (Completed, started 2018-05-20)
Frequently asked questions
How many FDA 510(k) clearances are listed under Augmedics, Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Augmedics, Ltd.” (first 2019, latest 2026), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Augmedics, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Augmedics, Ltd. is 127 days. Since 2017: 127 days, versus 111 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Augmedics, Ltd.?
The most frequent FDA product codes under this applicant name are SBF (Orthopedic Augmented Reality, 7).
Next steps
- See all 7 Augmedics, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code SBF, Augmedics, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.