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 AbbVieLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record. See the AbbVie group view.
As of Nov 14, 2026, FDA's public records list Soliton, Inc. with 5 510(k) clearances. The most recent is a 510(k) clearance dated Nov 5, 2021: Resonic Rapid Acoustic Pulse Device.
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.
| Nov 5, 2021 | Resonic Rapid Acoustic Pulse DeviceK212502 · GEX | 510(k) clearances |
| Apr 27, 2021 | Resonic Rapid Acoustic Pulse DeviceK210964 · GEX | 510(k) clearances |
| Jan 29, 2021 | Rapid Acoustic Pulse DeviceK201801 · GEX | 510(k) clearances |
| Mar 10, 2020 | Rapid Acoustic Pulse DeviceK200331 · GEX | 510(k) clearances |
| May 24, 2019 | Soliton Acoustic Wave DeviceK190542 · GEX | 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
