Edap Technomed Inc.
Austin, TX, US
Edap Technomed Inc. appears in FDA device records in Austin, TX. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Edap Technomed Inc. between 2001 and 2025. The busiest year on record is 2001, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251910 | Focal One® | PLP | Substantially Equivalent | |
| K172721 | FOCAL ONE | PLP | Substantially Equivalent | |
| K172285 | Ablatherm Fusion | PLP | Substantially Equivalent | |
| K153023 | Ablatherm Integrated Imaging | PLP | Substantially Equivalent | |
| K003529 | SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS | LNS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1287394 | 1287394 | Edap Technomed Inc. | 5321 Industrial Oaks Blvd, Austin, TX 78735 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0049-2018 | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain