Data / Medical devices / Catheter, Urological / United States
FDA-registered makers of Catheter, Urological in the United States: 20 establishments
20 establishments in the United States are registered with the FDA to make Catheter, Urological (product code KOD). 14 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 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.
- Device
- Catheter, Urological
- Product code
- KOD
- Country
- United States
Makers of Catheter, Urological 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 | 10 | June 28, 2018 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 9 | June 28, 2018 | 0 | 1 | 0 | api.fda.gov |
| C.R. Bard, Inc. | Covington, GA, United States | Complaint file establishment, Contract sterilizer, Manufacturer, Specification developer | 8 | February 23, 2026 | 0 | 8 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 8 | July 20, 2004 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 6 | May 24, 2019 | 0 | 6 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 3 | April 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer | 2 | March 10, 1987 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 2 | March 10, 1987 | 0 | 0 | 0 | api.fda.gov |
| Hollister Incorporated | Libertyville, IL, United States | Specification developer | 2 | January 9, 2004 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Complaint file establishment, Specification developer | 2 | July 21, 1982 | 0 | 0 | 0 | api.fda.gov |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer, Manufacturer for export | 1 | October 13, 2022 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Lafayette, CO, United States | Specification developer | 1 | August 10, 1983 | 0 | 0 | 0 | api.fda.gov |
| HR PHARMACEUTICALS, INC d/b/a HR HealthCare | York, PA, United States | Complaint file establishment, Specification developer | 1 | July 17, 2008 | 0 | 0 | 0 | api.fda.gov |
| Nurse Assist, LLC | Haltom City, TX, United States | Manufacturer | 1 | March 17, 1983 | 0 | 2 | 0 | api.fda.gov |
| A+ Secure Packaging | La Vergne, TN, United States | Contract manufacturer | 0 | 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 | |
| Cook Medical LLC | Bloomington, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Robling Medical, LLC | Youngsville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xeridiem Medical Devices | Tucson, AZ, 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.