Data / Medical devices / United States / Teal Health, Inc.
Teal Health, Inc.: FDA-registered device maker in San Francisco, CA, United States, 1 510(k) clearance
Teal Health, Inc. is registered with the FDA (registration 3027195609) in San Francisco, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 9, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3027195609
- Address
- 39 Mesa St Ste 212, San Francisco, CA, United States, 94129
- Owner or operator
- Teal Health, Inc. (10093528)
- Roles
- Specification developer
- First device listed
- May 29, 2025
- Registered through
- 2027
- Brand names listed
- Teal Wand Vaginal Sample Self-Collection Device for Cervical Cancer Screening
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay | SEP | 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 |
|---|---|---|---|---|---|---|
| May 9, 2025 | DEN240045 | Teal Wand | SEP | Unknown | Teal Health, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 9, 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.