Edap Technomed Inc.
United Statesfrom the FDA registration address FDA establishment FEI 1287394
- Devices
- 5
- Registrations
- FDA
- FDA recalls
- 1
Catalogue
Focal One Ref K172721
Regimes: 510(k) Registry: 510(k)Sonolith Praktis, Endourology Table Praktis Ref K003529
Regimes: 510(k) Registry: 510(k)Ablatherm Fusion Ref K172285
Regimes: 510(k) Registry: 510(k)Ablatherm Integrated Imaging Ref K153023
Regimes: 510(k) Registry: 510(k)Focal One® Ref K251910
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1287394
- Address
- 5321 Industrial Oaks Blvd, Austin, TX, 78735
FDA recalls
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 14 Aug 2017 Z-0049-2018 Class II Terminated 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.
Frequently asked questions
How many devices does Edap Technomed Inc. have in the registry?
The registry currently lists 5 devices for Edap Technomed Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Edap Technomed Inc.'s devices?
Among its 5 most recently registered devices, Edap Technomed Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Edap Technomed Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Edap Technomed Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Edap Technomed Inc.?
FDA recall records list 1 recall initiated by Edap Technomed Inc., the most recent initiated on 2017-08-14. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Edap Technomed Inc. in the registry?
The most recently registered devices listed for Edap Technomed Inc. include FOCAL ONE, SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS, Ablatherm Fusion and Ablatherm Integrated Imaging.