Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of BioventusLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Bioness with 13 510(k) clearances. The most recent is a 510(k) clearance dated Feb 23, 2022: StimRouter Neuromodulation 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.
| Feb 23, 2022 | StimRouter Neuromodulation SystemK211965 · GZF | 510(k) clearances |
| Mar 27, 2020 | StimRouter Neuromodulation SystemK200482 · GZF | 510(k) clearances |
| Mar 4, 2020 | L100 Go SystemK200262 · GZI | 510(k) clearances |
| Oct 31, 2019 | StimRouter Neuromodulation SystemK190047 · GZF | 510(k) clearances |
| Sep 12, 2019 | L360 Thigh SystemK191587 · GZI | 510(k) clearances |
| Mar 14, 2019 | L300 Go SystemK190285 · GZI | 510(k) clearances |
| Mar 9, 2018 | L300 Go SystemK173682 · GZI | 510(k) clearances |
| Jan 27, 2017 | L300 Go SystemK162407 · GZI | 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
