Data / Medical devices / Ear, Nose, And Throat Stereotaxic Instrument / Germany
FDA-registered makers of Ear, Nose, And Throat Stereotaxic Instrument in Germany: 10 establishments
10 establishments in Germany are registered with the FDA to make Ear, Nose, And Throat Stereotaxic Instrument (product code PGW). 4 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Ear, Nose, And Throat Stereotaxic Instrument
- Product code
- PGW
- Country
- Germany
Makers of Ear, Nose, And Throat Stereotaxic Instrument in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Fiagon GMBH | Hennigsdorf Brandenburg, Germany | Manufacturer | 9 | June 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Stryker Leibinger GMBH & Co. KG | FREIBURG Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 5 | July 12, 2022 | 0 | 1 | 0 | api.fda.gov |
| Brainlab Se | Munich Bavaria, Germany | Manufacturer | 1 | April 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 1 | October 21, 2016 | 0 | 0 | 0 | api.fda.gov |
| Eurofins STERIPAC GMBH | Calw-Altburg Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Josef Frech GMBH & Co. KG | Konigsheim Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS Martin SE & Co. KG | Muhlheim/Donau Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ossenbrueggen Feinwerktechnik GMBH & Co. KG | Moorrege Schleswig-Holstein, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.