Data / Medical devices / United States / Edap Technomed Inc.
Edap Technomed Inc.: FDA-registered device maker in Austin, TX, United States, 3 510(k) clearances
Edap Technomed Inc. is registered with the FDA (registration 1287394) in Austin, TX, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated November 19, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1287394
- Address
- 5321 Industrial Oaks Blvd Suite 110, Austin, TX, United States, 78735
- Owner or operator
- EDAP Technomed Inc. (10040253)
- Roles
- Complaint file establishment
- First device listed
- June 7, 2018
- Registered through
- 2026
- Brand names listed
- Ablatherm Fusion, Focal One, Focal One i
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| High Intensity Ultrasound System For Prostate Tissue Ablation | PLP | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 19, 2025 | K251910 | Focal One® | PLP | Substantially Equivalent | Edap Technomed, Inc. | accessdata.fda.gov |
| June 7, 2018 | K172721 | FOCAL ONE | PLP | Substantially Equivalent | Edap Technomed, Inc. | accessdata.fda.gov |
| October 3, 2017 | K172285 | Ablatherm Fusion | PLP | Substantially Equivalent | Edap Technomed, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 14, 2017 | 78092 | Class II | Terminated | Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue | The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Protocols 02-Medium and 03-Low) be removed from all Ablatherm Integrated Imagining devices in the U.S. until supporting clinical data can be submitted and evaluated by FDA. | accessdata.fda.gov |
Compare with other makers
Updated November 19, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.