Data / Medical devices / Catheter, Irrigation / United States
FDA-registered makers of Catheter, Irrigation in the United States: 69 establishments
69 establishments in the United States are registered with the FDA to make Catheter, Irrigation (product code GBX). 9 have a 510(k) clearance or PMA approval on file and 8 have a recall event. FDA data exported November 3, 2026.
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- Device
- Catheter, Irrigation
- Product code
- GBX
- Country
- United States
Makers of Catheter, Irrigation in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Axiom Medical, Inc. | Torrance, CA, United States | Manufacturer | 1 | March 10, 1997 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Sinking Spring, PA, United States | Manufacturer | 1 | April 22, 1991 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Lake Forest, CA, United States | Specification developer | 1 | April 22, 1991 | 0 | 0 | 0 | api.fda.gov |
| Arrow International, LLC (subsidiary of Teleflex Incorporated) | Wyomissing, PA, United States | Specification developer | 1 | December 27, 1989 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 1 | May 31, 1996 | 0 | 0 | 0 | api.fda.gov |
| Cook Biotech, Inc. | West Lafayette, IN, United States | Manufacturer | 1 | March 6, 1991 | 0 | 0 | 0 | api.fda.gov |
| Linvatec Corporation | Largo, FL, United States | Specification developer | 1 | June 26, 1985 | 0 | 1 | 0 | api.fda.gov |
| Maquet Cardiovascular LLC | Wayne, NJ, United States | Manufacturer | 1 | December 17, 2008 | 0 | 1 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | December 27, 1989 | 0 | 0 | 0 | api.fda.gov |
| Angiodynamics, Inc. | Queensbury, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Armm, Inc. | Huntington Beach, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AngioDynamics, Inc. | Marlborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Ave Maria, FL, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Instruments & Implants | Fort Wayne, IN, United States | Contract 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 | |
| Becton, Dickinson And Company | Irvine, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bard Access Systems, Inc. | Salt Lake City, UT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bentec Medical OpCo, LLC. | Woodland, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C.R. Bard, Inc. | Queensbury, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C.R. Bard, Inc. | Covington, GA, United States | Complaint file establishment, Contract sterilizer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Cardinal Health P.R. 218, Inc. | Anasco, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Centese, Inc. | Omaha, NE, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Clearflow, Inc | Irvine, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Command Medical Products, LLC. | Ormond Beach, FL, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences Technology Sarl | Anasco, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Em Device Lab, Inc. | Austin, TX, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon, Inc. | Somerville, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethicon, Inc. | Raritan, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Grace Medical, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harwood Design, Inc. | Bristol, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hollister Incorporated | Libertyville, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hollister Incorporated | Stuarts Draft, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Icu Medical, Inc. | Lake Forest, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Isomedix Operations Inc. | Spartanburg, SC, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations, Inc. | Libertyville, IL, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations, Inc. | Libertyville, IL, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| KMD Surgical Solutions, Inc. | Winston Salem, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lucas Medical, Inc. | Orange, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MAR-MED Inc. | Grand Rapids, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mcdougall Medtech, LLC | Dania Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Components Inc | Harleysville, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Medical Systems, Inc. | Houston, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Needle Specialty Products | Boyle, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Occam Design | Louisville, KY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quick Tube Medical, LLC | Knoxville, TN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sam Medical Products | Tualatin, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Silicone Medical Products & Services | Flowery Branch, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steven Label LLC | Santa Fe Springs, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thermasolutions LLC. | White Bear Lake, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tools For Surgery, LLC | Stony Brook, NY, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trimedyne, Inc. | Corona, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TeleMed Systems | Northborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Xeridiem Medical Devices | Tucson, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.