Edap Technomed Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1287394 | 1287394 | Edap Technomed Inc. | 1 | Y | 2026-01-01 | 5321 Industrial Oaks Blvd Suite 110 Austin TX US 78735 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 139797 | 2032634573 | K251910 | Focal One® | PLP | 2025-11-19 |
| 139797 | 1282799805 | K172721 | FOCAL ONE | PLP | 2018-06-07 |
| 139797 | 1019957445 | K172285 | Ablatherm Fusion | PLP | 2017-10-03 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PLP | 3 | 2025-11-19 |