Data / Medical devices / System, Irrigation, Urological / United States
FDA-registered makers of System, Irrigation, Urological in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make System, Irrigation, Urological (product code LJH). 9 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
- System, Irrigation, Urological
- Product code
- LJH
- Country
- United States
Makers of System, Irrigation, Urological in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Karl Storz Endoscopy-America, Inc. | Auburn, MA, United States | Contract manufacturer, Repackager or relabeler | 5 | July 7, 2017 | 0 | 0 | 0 | api.fda.gov |
| Avid Medical, Inc. A Medical Action Ind. Company 305 | Toano, VA, United States | Manufacturer, Repackager or relabeler | 1 | March 10, 2003 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 1 | September 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Complaint file establishment, Specification developer | 1 | May 14, 1996 | 0 | 0 | 0 | api.fda.gov |
| DePuy Mitek, Inc. | Raynham, MA, United States | Specification developer | 1 | May 8, 1998 | 0 | 0 | 0 | api.fda.gov |
| Intl. Medsurg Connection, Inc. | Schaumburg, IL, United States | Specification developer | 1 | March 10, 2003 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | June 10, 1997 | 0 | 0 | 0 | api.fda.gov |
| Stryker Endoscopy | San Jose, CA, United States | Specification developer | 1 | October 25, 2004 | 0 | 1 | 0 | api.fda.gov |
| Stryker Puerto Rico, LLC. | Arroyo, PR, United States | Manufacturer | 1 | October 25, 2004 | 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 | |
| B. Braun Us Device Manufacturing LLC | Allentown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nexus Medical, LLC | Lenexa, KS, 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.