Data / Medical devices / Netherlands / Bayer Medical Care B.V.
Bayer Medical Care B.V.: FDA-registered device maker in Maastricht Limburg, Netherlands, 1 510(k) clearance
Bayer Medical Care B.V. is registered with the FDA (registration 3012469182) in Maastricht Limburg, Netherlands. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 4, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3012469182
- Address
- Avenue Ceramique 27, Maastricht Limburg, Netherlands, 6221 KV
- Owner or operator
- Bayer AG (10094587)
- Roles
- Specification developer
- First device listed
- December 9, 2025
- Registered through
- 2026
- Brand names listed
- Ball Joint Guide Array (BJGA)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| September 4, 2025 | K250893 | Ball Joint Guide Array (66295) | HAW | Substantially Equivalent | Bayer Medical Care, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 4, 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.