Data / Medical devices / Catheter, Ureteral, Gastro-Urology / United States
FDA-registered makers of Catheter, Ureteral, Gastro-Urology in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Catheter, Ureteral, Gastro-Urology (product code EYB). 9 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Catheter, Ureteral, Gastro-Urology
- Product code
- EYB
- Country
- United States
Makers of Catheter, Ureteral, Gastro-Urology 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 | 5 | August 5, 2019 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 5 | August 5, 2019 | 0 | 0 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 2 | March 3, 2005 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Resources Corp. | Rsm, CA, United States | Complaint file establishment, Manufacturer | 1 | April 18, 1994 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Distribution Center | Irvine, CA, United States | Manufacturer | 1 | April 18, 1994 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 1 | January 8, 2014 | 0 | 0 | 0 | api.fda.gov |
| C.R. Bard, Inc. | Covington, GA, United States | Contract sterilizer, Specification developer | 1 | November 14, 2003 | 0 | 0 | 0 | api.fda.gov |
| Dornier Medtech America, Inc. | Kennesaw, GA, United States | Specification developer | 1 | September 18, 2019 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | January 21, 2010 | 0 | 1 | 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 | |
| Cook Medical LLC | Bloomington, IN, 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.