Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Augmedics with 7 510(k) clearances, 3 AI-enabled devices and 1 device recall. The most recent is a 510(k) clearance dated Jul 31, 2026: xvision Spine system.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jul 31, 2026 | xvision Spine systemK261854 · SBF | 510(k) clearances |
| Oct 3, 2025 | xvision Spine systemK251639 · SBF | 510(k) clearances |
| Oct 3, 2025 | xvision Spine systemK251639 · Neurology | AI-enabled devices |
| Apr 14, 2025 | Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation systemClass II · The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings foun | Device recalls |
| Mar 13, 2025 | xvision Spine systemK250255 · SBF | 510(k) clearances |
| Mar 13, 2025 | xvision Spine systemK250255 · Neurology | AI-enabled devices |
| Oct 16, 2024 | xvision Spine SystemK241481 · SBF | 510(k) clearances |
| Oct 16, 2024 | xvision Spine SystemK241481 · Neurology | AI-enabled devices |
| Nov 17, 2022 | xvision Spine SystemK220905 · SBF | 510(k) clearances |
| Jul 19, 2021 | xvision Spine system (XVS)K211188 · SBF | 510(k) clearances |
| Dec 20, 2019 | xvision Spine system (XVS)K190929 · SBF | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
