Company · US
Edap Technomed, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2025. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 19, 2025 | K251910 | Focal One® Edap Technomed, Inc. | PLP |
| Jun 7, 2018 | K172721 | FOCAL ONE Edap Technomed, Inc. | PLP |
| Oct 3, 2017 | K172285 | Ablatherm Fusion Edap Technomed, Inc. | PLP |
| Nov 6, 2015 | K153023 | Ablatherm Integrated Imaging Edap Technomed, Inc. | PLP |
| Feb 12, 2001 | K003529 | SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS Edap Technomed, Inc. | LNS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2017 | Edap Technomed Inc. Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation
Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue Terminated |
PLP | K153023 |