Data / Medical devices / Accessories, Catheter, G-U / United States
FDA-registered makers of Accessories, Catheter, G-U in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Accessories, Catheter, G-U (product code KNY). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Accessories, Catheter, G-U
- Product code
- KNY
- Country
- United States
Makers of Accessories, Catheter, G-U in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 2 | February 4, 2013 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Resources Corp. | Rsm, CA, United States | Complaint file establishment, Manufacturer | 1 | September 21, 1994 | 0 | 0 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Contract manufacturer, Manufacturer | 1 | April 23, 1999 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Distribution Center | Irvine, CA, United States | Manufacturer | 1 | September 21, 1994 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 1 | April 25, 1995 | 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 | |
| EPIC MedTec OEM Catheter & Wire LLC | Plymouth, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Icu Medical, Inc | Salt Lake City, UT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lake Region Medical | Chaska, MN, 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.