Data / Medical devices / Accelerator, Linear, Medical / Germany
FDA-registered makers of Accelerator, Linear, Medical in Germany: 12 establishments
12 establishments in Germany are registered with the FDA to make Accelerator, Linear, Medical (product code IYE). 10 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.
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- Device
- Accelerator, Linear, Medical
- Product code
- IYE
- Country
- Germany
Makers of Accelerator, Linear, Medical in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Brainlab Se | Munich Bavaria, Germany | Exporter to the US, Manufacturer | 13 | January 14, 2026 | 0 | 14 | 0 | api.fda.gov |
| IBA Dosimetry GmbH | SCHWARZENBRUCK Bavaria, Germany | Manufacturer | 11 | September 18, 2009 | 0 | 5 | 0 | api.fda.gov |
| Siemens Healthineers AG Varian Cancer Therapy (CTH) | Erlangen Bavaria, Germany | Specification developer | 11 | November 21, 2014 | 0 | 0 | 0 | api.fda.gov |
| PTW Freiburg | FREIBURG Baden-Wurttemberg, Germany | Manufacturer | 9 | April 15, 2026 | 0 | 4 | 0 | api.fda.gov |
| Varian Medical Systems Haan GmbH Manufacturing site Kemnath | Kemnath Bavaria, Germany | Manufacturer | 4 | January 21, 2026 | 0 | 0 | 0 | api.fda.gov |
| 3C-Medical Intelligence GmbH | Landsberg am Lech Bavaria, Germany | Manufacturer | 3 | March 4, 2015 | 0 | 1 | 0 | api.fda.gov |
| Varian Medical Systems Haan GmbH | Haan North Rhine-Westphalia, Germany | Manufacturer | 3 | December 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Lap GMBH Laser Applikationen | LUENEBURG Lower Saxony, Germany | Manufacturer | 2 | March 29, 2024 | 0 | 0 | 0 | api.fda.gov |
| Inomed Medizintechnik GMBH | EMMENDINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | March 23, 1990 | 0 | 0 | 0 | api.fda.gov |
| iRT Systems GmbH | Koblenz Rhineland-Palatinate, Germany | Complaint file establishment, Manufacturer | 1 | October 20, 2016 | 0 | 0 | 0 | api.fda.gov |
| Medcom GMBH | Darmstadt Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meiser Medical GMBH | Neuenstein Hesse, 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.