Data / Medical devices / System, Surgical, Computer Controlled Instrument / Germany
FDA-registered makers of System, Surgical, Computer Controlled Instrument in Germany: 11 establishments
11 establishments in Germany are registered with the FDA to make System, Surgical, Computer Controlled Instrument (product code NAY). 4 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- System, Surgical, Computer Controlled Instrument
- Product code
- NAY
- Country
- Germany
Makers of System, Surgical, Computer Controlled Instrument in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| AKTORmed GmbH | Neutraubling Bavaria, Germany | Manufacturer | 2 | December 22, 2020 | 0 | 0 | 0 | api.fda.gov |
| Intuitive Surgical Optics GmbH | Freiburg Baden-Wurttemberg, Germany | Manufacturer | 2 | March 14, 2024 | 0 | 0 | 0 | api.fda.gov |
| Intuitive Surgical Optics GmbH | Emmendingen Baden-Wurttemberg, Germany | Manufacturer | 2 | March 14, 2024 | 0 | 0 | 0 | api.fda.gov |
| Novanta Medical GmbH | Berlin, Germany | Specification developer | 1 | March 14, 2024 | 0 | 0 | 0 | api.fda.gov |
| Bowa-Electronic GMBH | GOMARINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurofins STERIPAC GMBH | Calw-Altburg Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guenter Bissinger Medizintechnik GMBH | TENINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hupfer Metallwerke GMBH & Co. KG | Coesfeld North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Koscher & Wuertz GMBH | SPAICHINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novanta Medical GmbH | LUDWIGSSTADT Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Schoelly Fiberoptic, GMBH | DENZLINGEN Baden-Wurttemberg, 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.