Data / Medical devices / Germany / Od-Os GMBH
Od-Os GMBH: FDA-registered device maker in Teltow Brandenburg, Germany, 2 510(k) clearances
Od-Os GMBH is registered with the FDA (registration 3008252121) in Teltow Brandenburg, Germany. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 29, 2025. Registered through 2027. 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.
- FDA registration number
- 3008252121
- Address
- Warthestr. 21, Teltow Brandenburg, Germany, 14513
- Owner or operator
- OD-OS GmbH (10031430)
- Roles
- Manufacturer
- First device listed
- November 21, 2017
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Ophthalmic, Ac-Powered | HKI | 2 | Manufacturer | accessdata.fda.gov |
| Device, Communications, Images, Ophthalmic | NFG | 1 | Manufacturer | accessdata.fda.gov |
| Device, Storage, Images, Ophthalmic | NFF | 1 | Manufacturer | accessdata.fda.gov |
| Laser, Ophthalmic | HQF | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 29, 2025 | K251772 | Navilas Laser System 577sl (156691) | HQF | Substantially Equivalent | Od-Os GmbH | accessdata.fda.gov |
| November 22, 2016 | K162191 | NAVILAS Laser System | GEX | Substantially Equivalent | Od-Os GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Camera, Ophthalmic, Ac-Powered
- All makers of Device, Storage, Images, Ophthalmic
- All makers of Device, Communications, Images, Ophthalmic
- All makers of Laser, Ophthalmic
Updated October 29, 2025. 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.