Data / Medical devices / France / Pixee Medical
Pixee Medical: FDA-registered device maker in Besancon Doubs, France, 6 510(k) clearances
Pixee Medical is registered with the FDA (registration 3020703212) in Besancon Doubs, France. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 24, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3020703212
- Address
- 18 rue Alain Savary, Besancon Doubs, France, 25000
- Owner or operator
- Pixee Medical (10082044)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 6, 2021
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscope, Neurological | GWG | 2 | Exporter to the US | accessdata.fda.gov |
| Holder, Camera, Surgical | FXR | 1 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Exporter to the US | accessdata.fda.gov |
| Orthopedic Augmented Reality | SBF | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | 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 |
|---|---|---|---|---|---|---|
| April 24, 2026 | K253805 | Knee+ | SBF | Substantially Equivalent | Pixee Medical S.A.S. | accessdata.fda.gov |
| March 20, 2025 | K243975 | Knee+ | SBF | Substantially Equivalent | Pixee Medical | accessdata.fda.gov |
| March 8, 2024 | K233899 | Knee+ | SBF | Substantially Equivalent | Pixee Medical | accessdata.fda.gov |
| April 21, 2023 | K230789 | Knee+ | SBF | Substantially Equivalent | Pixee Medical | accessdata.fda.gov |
| September 1, 2022 | K220104 | Knee+ | SBF | Substantially Equivalent | Pixee Medical | accessdata.fda.gov |
| November 23, 2005 | K052745 | ASSISTO ARM SYSTEMS | GWG | Substantially Equivalent | Geomed Medizin-Technik GmbH & Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopedic Augmented Reality
- All makers of Holder, Camera, Surgical
- All makers of Tray, Surgical, Instrument
- All makers of Endoscope, Neurological
- All makers of Laparoscope, General & Plastic Surgery
Updated April 24, 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.