Data / Medical devices / Catheter, Nephrostomy / United States
FDA-registered makers of Catheter, Nephrostomy in the United States: 19 establishments
19 establishments in the United States are registered with the FDA to make Catheter, Nephrostomy (product code LJE). 10 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.
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- Device
- Catheter, Nephrostomy
- Product code
- LJE
- Country
- United States
Makers of Catheter, Nephrostomy 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 | 11 | January 29, 2020 | 0 | 4 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 10 | January 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 2 | January 10, 2018 | 0 | 1 | 0 | api.fda.gov |
| C.R. Bard, Inc. | Covington, GA, United States | Contract sterilizer, Repackager or relabeler, Specification developer | 2 | October 23, 2008 | 0 | 1 | 0 | api.fda.gov |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer | 1 | January 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 1 | September 18, 2012 | 0 | 1 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 1 | September 18, 2012 | 0 | 0 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Specification developer | 1 | February 4, 2014 | 0 | 0 | 0 | api.fda.gov |
| Retroperc, Inc. | Jersey City, NJ, United States | Specification developer | 1 | July 12, 2016 | 0 | 0 | 0 | api.fda.gov |
| Uresil, LLC | Skokie, IL, United States | Manufacturer | 1 | April 8, 1998 | 0 | 0 | 0 | api.fda.gov |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Argon Medical Devices Inc. | Athens, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atc Technologies Inc. | Wilmington, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Auris Health, Inc | Santa Clara, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Auris Health, Inc. | San Jose, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerics Fmi | Athens, TX, 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 | |
| Goodwill Commercial Services | Indianapolis, IN, United States | Contract manufacturer | 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.