Data / Medical devices / United States / W. L. Gore & Associates, Inc.
W. L. Gore & Associates, Inc.: FDA-registered device maker in Santa Clara, CA, United States, 1 PMA approval
W. L. Gore & Associates, Inc. is registered with the FDA (registration 3013164176) in Santa Clara, CA, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated November 6, 2002. Registered through 2027. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3013164176
- Address
- 2890 De La Cruz Blvd, Santa Clara, CA, United States, 95050
- Owner or operator
- W. L. GORE & ASSOCIATES, INC. (9925013)
- Roles
- Manufacturer
- First device listed
- December 18, 2007
- Registered through
- 2027
- Brand names listed
- GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Endovascular Graft, Aortic Aneurysm Treatment | MIH | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 6, 2002 | P020004 | EXCLUDER BIFURCATED ENDOPROSTHESIS | MIH | 199 | July 8, 2026 | accessdata.fda.gov |
Compare with other makers
Updated July 8, 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.