Data / Medical devices / Dilator, Urethral / United States
FDA-registered makers of Dilator, Urethral in the United States: 15 establishments
15 establishments in the United States are registered with the FDA to make Dilator, Urethral (product code KOE). 6 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Dilator, Urethral
- Product code
- KOE
- Country
- United States
Makers of Dilator, Urethral 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, Specification developer | 5 | October 10, 1997 | 0 | 1 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer, Manufacturer for export | 4 | October 18, 1996 | 0 | 1 | 0 | api.fda.gov |
| Atrion Medical Products, Inc. | Arab, AL, United States | Manufacturer | 3 | March 3, 2004 | 0 | 0 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Manufacturer, Repackager or relabeler | 1 | March 3, 2004 | 0 | 0 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | March 3, 2004 | 0 | 0 | 0 | api.fda.gov |
| Urotronic Inc | Plymouth, MN, United States | Manufacturer | 1 | January 2, 2020 | 0 | 0 | 0 | api.fda.gov |
| Biomerics Fmi | Athens, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Coventry, RI, United States | 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 | |
| C.R. Bard, Inc. | Covington, GA, United States | Contract sterilizer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dornier Medtech America, Inc. | Kennesaw, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Goodwill Commercial Services | Indianapolis, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STERIS Corporation | Saint Louis, MO, United States | Specification developer | 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.