Data / Medical devices / United States / Mendaera, Inc.
Mendaera, Inc.: FDA-registered device maker in San Mateo, CA, United States, 1 510(k) clearance
Mendaera, Inc. is registered with the FDA (registration 3031851875) in San Mateo, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031851875
- Address
- 700 S Claremont St Ste 200, San Mateo, CA, United States, 94402
- Owner or operator
- Mendaera, Inc. (10093797)
- Roles
- Manufacturer, Specification developer
- First device listed
- July 11, 2025
- Registered through
- 2026
- Brand names listed
- ARM BOX KIT, ARM DRAPE BOX KIT, BOX KIT, DRAPE, ARM, BOX KIT, DRAPE, ARM, FOCALIST, BOX KIT, DRAPE, FULL, BOX KIT, DRAPE, FULL, FOCALIST, BOX KIT, INSTRUMENT INTERFACE, LONG, FOCALIST, BOX KIT, INSTRUMENT INTERFACE, SHORT, FOCALIST and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| July 2, 2025 | K250524 | Mendaera Guidance System | ITX | Substantially Equivalent | Mendaera, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 2, 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.