Data / Medical devices / United States / Materna Medical
Materna Medical: FDA-registered device maker in Mountain View, CA, United States, 2 510(k) clearances
Materna Medical is registered with the FDA (registration 3014485094) in Mountain View, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated February 27, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014485094
- Address
- 2495 Hospital Drive Suite 300, Mountain View, CA, United States, 94040
- Owner or operator
- Materna Medical (10084276)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 2, 2022
- Registered through
- 2026
- Brand names listed
- Milli Vaginal Dilator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dilator, Vaginal | HDX | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| February 27, 2023 | K220035 | Milli Vaginal Dilator | HDX | Substantially Equivalent | Materna Medical | accessdata.fda.gov |
| December 1, 2021 | K211959 | Milli Vaginal Dilator | HDX | Substantially Equivalent | Materna Medical | accessdata.fda.gov |
Compare with other makers
Updated February 27, 2023. 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.