Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list EDAP TMS with 5 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Nov 19, 2025: Focal One®.
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 |
|---|---|---|
| Nov 19, 2025 | Focal One®K251910 · PLP | 510(k) clearances |
| Jun 7, 2018 | FOCAL ONEK172721 · PLP | 510(k) clearances |
| Oct 3, 2017 | Ablatherm FusionK172285 · PLP | 510(k) clearances |
| Aug 14, 2017 | Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasClass II · The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Protocols 02-Medium and 03 | Device recalls |
| Nov 6, 2015 | Ablatherm Integrated ImagingK153023 · PLP | 510(k) clearances |
| Feb 12, 2001 | SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTISK003529 · LNS | 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
