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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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Axiom Medical, Inc.Torrance, CA, United StatesManufacturer1March 10, 1997000api.fda.gov
Alcon Research, LLCSinking Spring, PA, United StatesManufacturer1April 22, 1991000api.fda.gov
Alcon Research, LLCLake Forest, CA, United StatesSpecification developer1April 22, 1991000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer1December 27, 1989000api.fda.gov
B. Braun Medical Inc.Bethlehem, PA, United StatesSpecification developer1May 31, 1996000api.fda.gov
Cook Biotech, Inc.West Lafayette, IN, United StatesManufacturer1March 6, 1991000api.fda.gov
Linvatec CorporationLargo, FL, United StatesSpecification developer1June 26, 1985010api.fda.gov
Maquet Cardiovascular LLCWayne, NJ, United StatesManufacturer1December 17, 2008010api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1December 27, 1989000api.fda.gov
Angiodynamics, Inc.Queensbury, NY, United StatesManufacturer0000api.fda.gov
Armm, Inc.Huntington Beach, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
AngioDynamics, Inc.Marlborough, MA, United StatesSpecification developer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
B. Braun Us Device Manufacturing LLCAllentown, PA, United StatesContract manufacturer0000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Bard Access Systems, Inc.Salt Lake City, UT, United StatesSpecification developer0000api.fda.gov
Bentec Medical OpCo, LLC.Woodland, CA, United StatesManufacturer0000api.fda.gov
C.R. Bard, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesComplaint file establishment, Contract sterilizer, Specification developer0010api.fda.gov
Cardinal Health P.R. 218, Inc.Anasco, PR, United StatesManufacturer0000api.fda.gov
Centese, Inc.Omaha, NE, United StatesManufacturer0010api.fda.gov
Clearflow, IncIrvine, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Command Medical Products, LLC.Ormond Beach, FL, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0020api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Deroyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer0000api.fda.gov
Em Device Lab, Inc.Austin, TX, United StatesManufacturer, Specification developer0000api.fda.gov
Ethicon, Inc.Somerville, NJ, United StatesManufacturer0000api.fda.gov
Ethicon, Inc.Raritan, NJ, United StatesManufacturer0000api.fda.gov
Grace Medical, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
Hollister IncorporatedLibertyville, IL, United StatesSpecification developer0000api.fda.gov
Hollister IncorporatedStuarts Draft, VA, United StatesManufacturer0000api.fda.gov
Icu Medical, Inc.Lake Forest, IL, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Isomedix Operations Inc.Spartanburg, SC, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Isomedix Operations, Inc.Libertyville, IL, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Isomedix Operations, Inc.Libertyville, IL, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
KMD Surgical Solutions, Inc.Winston Salem, NC, United StatesSpecification developer0000api.fda.gov
Lucas Medical, Inc.Orange, CA, United StatesManufacturer0000api.fda.gov
MAR-MED Inc.Grand Rapids, MI, United StatesManufacturer0000api.fda.gov
Mcdougall Medtech, LLCDania Beach, FL, United StatesContract manufacturer0000api.fda.gov
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0010api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer0000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer, Specification developer0000api.fda.gov
Merit Medical Systems, Inc.Houston, TX, United StatesContract manufacturer0000api.fda.gov
Needle Specialty ProductsBoyle, MS, United StatesContract manufacturer0000api.fda.gov
Occam DesignLouisville, KY, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Quick Tube Medical, LLCKnoxville, TN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Sam Medical ProductsTualatin, OR, United StatesManufacturer0000api.fda.gov
Silicone Medical Products & ServicesFlowery Branch, GA, United StatesManufacturer0000api.fda.gov
Steven Label LLCSanta Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesSpecification developer0000api.fda.gov
Thermasolutions LLC.White Bear Lake, MN, United StatesSpecification developer0000api.fda.gov
Tools For Surgery, LLCStony Brook, NY, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Trimedyne, Inc.Corona, CA, United StatesManufacturer, Specification developer0000api.fda.gov
TeleMed SystemsNorthborough, MA, United StatesSpecification developer0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0020api.fda.gov
Xeridiem Medical DevicesTucson, AZ, United StatesContract manufacturer0000api.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.