Data / Medical devices / Catheter, Urethral / United States
FDA-registered makers of Catheter, Urethral in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make Catheter, Urethral (product code GBM). 15 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, Urethral
- Product code
- GBM
- Country
- United States
Makers of Catheter, Urethral in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Hollister Incorporated | Libertyville, IL, United States | Specification developer | 9 | January 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 2 | June 23, 1989 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 2 | May 8, 2019 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 1 | April 6, 1983 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer | 1 | April 6, 1983 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 1 | April 6, 1983 | 0 | 0 | 0 | api.fda.gov |
| C.R. Bard, Inc. | Covington, GA, United States | Contract sterilizer, Manufacturer, Specification developer | 1 | August 23, 1976 | 0 | 1 | 0 | api.fda.gov |
| Compactcath, Inc | Palo Alto, CA, United States | Specification developer | 1 | February 13, 2012 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 1 | November 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 1 | November 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Greystone Medical, LLC | Waterford, MI, United States | Specification developer | 1 | February 13, 2012 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | June 12, 2019 | 0 | 0 | 0 | api.fda.gov |
| Multi-Med, Inc. | Keene, NH, United States | Contract manufacturer, Manufacturer | 1 | June 17, 2003 | 0 | 0 | 0 | api.fda.gov |
| Neochild, LLC | Oklahoma City, OK, United States | Manufacturer | 1 | February 24, 2006 | 0 | 0 | 0 | api.fda.gov |
| Utah Medical Products, Inc. | Midvale, UT, United States | Manufacturer | 1 | May 16, 1994 | 0 | 0 | 0 | api.fda.gov |
| Avanos Medical, Inc. | Alpharetta, GA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Molded Products Inc. | Harlan, IA, 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.