Data / Medical devices / Stent, Ureteral / United States
FDA-registered makers of Stent, Ureteral in the United States: 20 establishments
20 establishments in the United States are registered with the FDA to make Stent, Ureteral (product code FAD). 14 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.
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- Device
- Stent, Ureteral
- Product code
- FAD
- Country
- United States
Makers of Stent, Ureteral in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 13 | April 23, 2019 | 0 | 3 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 13 | April 23, 2019 | 0 | 5 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 8 | March 25, 1996 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 5 | April 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| C.R. Bard, Inc. | Covington, GA, United States | Contract sterilizer, Specification developer | 4 | December 7, 2004 | 0 | 2 | 0 | api.fda.gov |
| Applied Medical Resources Corp. | Rsm, CA, United States | Complaint file establishment, Manufacturer | 3 | March 29, 2006 | 0 | 1 | 0 | api.fda.gov |
| Applied Medical Distribution Center | Irvine, CA, United States | Manufacturer | 3 | March 29, 2006 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 3 | April 15, 2025 | 0 | 1 | 0 | api.fda.gov |
| The Ureteral Stent Company, Inc. | Beachwood, OH, United States | Specification developer | 2 | March 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer | 1 | December 2, 2019 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer | 1 | April 15, 2025 | 0 | 1 | 0 | api.fda.gov |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 1 | April 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Dornier Medtech America, Inc. | Kennesaw, GA, United States | Specification developer | 1 | November 15, 2019 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Specification developer | 1 | November 22, 2016 | 0 | 0 | 0 | api.fda.gov |
| Biomerics Fmi | Athens, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C.R. Bard, Inc. | Queensbury, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EPIC MedTec OEM Catheter & Wire LLC | Plymouth, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lake Region Medical | Chaska, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Martech Medical Products | Harleysville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Murray, Inc. | Lake Zurich, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.