Data / Medical devices / Catheter, Suprapubic (And Accessories) / United States
FDA-registered makers of Catheter, Suprapubic (And Accessories) in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Catheter, Suprapubic (And Accessories) (product code KOB). 7 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, Suprapubic (And Accessories)
- Product code
- KOB
- Country
- United States
Makers of Catheter, Suprapubic (And Accessories) 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 | 7 | January 18, 2019 | 0 | 2 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 7 | January 18, 2019 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 2 | February 7, 1997 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Technology, Inc. | Brecksville, OH, United States | Manufacturer | 1 | November 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Specification developer | 1 | September 19, 2001 | 0 | 0 | 0 | api.fda.gov |
| Swan Valley Medical, Incorporated | Denver, CO, United States | Complaint file establishment, Manufacturer | 1 | October 26, 2012 | 0 | 0 | 0 | api.fda.gov |
| Utah Medical Products, Inc. | Midvale, UT, United States | Manufacturer | 1 | October 25, 1988 | 0 | 0 | 0 | api.fda.gov |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nissha Medical Technologies (Ohio), Inc. | Norwalk, OH, 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.