Data / Medical devices / Interventional Fluoroscopic X-Ray System / France
FDA-registered makers of Interventional Fluoroscopic X-Ray System in France: 6 establishments
6 establishments in France are registered with the FDA to make Interventional Fluoroscopic X-Ray System (product code OWB). 5 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Interventional Fluoroscopic X-Ray System
- Product code
- OWB
- Country
- France
Makers of Interventional Fluoroscopic X-Ray System in France
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ge Medical Systems SCS | Buc, France | Manufacturer | 17 | December 9, 2025 | 0 | 2 | 0 | api.fda.gov |
| Stephanix | La Ricamarie Auvergne-Rhone-Alpes, France | Manufacturer | 2 | June 7, 2022 | 0 | 1 | 0 | api.fda.gov |
| Caranx Medical | Nice Provence-Alpes-Cote d'Azur, France | Manufacturer | 1 | July 7, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ecential Robotics | Gieres Isere, France | Manufacturer | 1 | March 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Therenva | Rennes Bretagne, France | Manufacturer | 1 | October 25, 2022 | 0 | 0 | 0 | api.fda.gov |
| Simagec | ROUSSET CEDEX Bouches-du-Rhone, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.