Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled 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.
As of Nov 13, 2026, FDA's public records list Sofwave Medical, Ltd. with 12 510(k) clearances. The most recent is a 510(k) clearance dated Jul 2, 2025: Pure Impact.
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 2, 2025 | Pure ImpactK251746 · NGX | 510(k) clearances |
| Apr 18, 2025 | SofWave SystemK250146 · NGX | 510(k) clearances |
| Aug 7, 2024 | SofWave SystemK241685 · NGX | 510(k) clearances |
| May 30, 2024 | SofWave SystemK240687 · OHV | 510(k) clearances |
| Dec 22, 2023 | SofWave SystemK233104 · OHV | 510(k) clearances |
| Dec 14, 2023 | SofWave SystemK232455 · OHV | 510(k) clearances |
| Aug 28, 2023 | SofWave SystemK231537 · OHV | 510(k) clearances |
| Apr 18, 2023 | SofWave SystemK230820 · OHV | 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
