Data / Medical devices / Interventional Fluoroscopic X-Ray System / Germany
FDA-registered makers of Interventional Fluoroscopic X-Ray System in Germany: 5 establishments
5 establishments in Germany are registered with the FDA to make Interventional Fluoroscopic X-Ray System (product code OWB). 4 have a 510(k) clearance or PMA approval on file and 1 has a recall event. 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.
- Device
- Interventional Fluoroscopic X-Ray System
- Product code
- OWB
- Country
- Germany
Makers of Interventional Fluoroscopic X-Ray System in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthineers AG | FORCHHEIM Bavaria, Germany | Contract manufacturer, Manufacturer, Specification developer | 37 | April 24, 2026 | 0 | 1 | 0 | api.fda.gov |
| Ziehm Imaging GMBH | Nuernberg, Bavaria, Germany | Manufacturer | 4 | March 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Brainlab Se | Munich Bavaria, Germany | Exporter to the US, Manufacturer | 3 | July 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Philips Medical Systems DMC GmbH | Hamburg, Germany | Complaint file establishment, Specification developer | 2 | February 5, 2018 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthineers AG | KEMNATH Bavaria, Germany | 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.