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Data / Medical devices / Introducer, Catheter / United States

FDA-registered makers of Introducer, Catheter in the United States: 113 establishments

113 establishments in the United States are registered with the FDA to make Introducer, Catheter (product code DYB). 85 have a 510(k) clearance or PMA approval on file and 26 have a recall event. FDA data exported November 2, 2026.

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Device
Introducer, Catheter
Product code
DYB
Country
United States

Makers of Introducer, Catheter in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
St. Jude Medical, Cardiology Division, Inc.Plymouth, MN, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Specification developer31December 13, 2024030api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer, Repackager or relabeler, Specification developer19April 25, 20250152api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer18March 25, 20240141api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesContract manufacturer, Manufacturer, Repackager or relabeler13December 15, 2025030api.fda.gov
Terumo Medical Corp.Elkton, MD, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler13January 6, 2020071api.fda.gov
Oscor Inc.Palm Harbor, FL, United StatesComplaint file establishment, Contract manufacturer, Manufacturer12June 3, 2021061api.fda.gov
St. Jude MedicalRoseville, MN, United StatesManufacturer, Manufacturer for export11December 13, 2024000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler11January 4, 2013000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer10January 4, 20130170api.fda.gov
Bard Access Systems, Inc.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer10November 4, 2016010api.fda.gov
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer10February 12, 2016010api.fda.gov
Medtronic, Inc.Mounds View, MN, United StatesSpecification developer10December 17, 2023021api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer9March 20, 2025000api.fda.gov
Cordis US Corp.Miami Lakes, FL, United StatesComplaint file establishment, Specification developer9April 24, 2023030api.fda.gov
ICU Medical, Inc.Dublin, OH, United StatesManufacturer8July 25, 2019000api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.Minnetonka, MN, United StatesManufacturer, Reprocessor, Specification developer8December 13, 2024060api.fda.gov
Greatbatch MedicalMinneapolis, MN, United StatesComplaint file establishment, Manufacturer, Specification developer6July 26, 20180100api.fda.gov
Abbott MedicalSylmar, CA, United StatesManufacturer, Specification developer5March 1, 2023000api.fda.gov
B. Braun Medical Inc.Bethlehem, PA, United StatesSpecification developer5July 15, 2003000api.fda.gov
Centerpoint Systems LLCWest Valley City, UT, United StatesComplaint file establishment, Manufacturer5June 5, 2026000api.fda.gov
Edwards Lifesciences LLCIrvine, CA, United StatesManufacturer, Specification developer5April 17, 2026010api.fda.gov
Galt Medical Corp.Garland, TX, United StatesComplaint file establishment, Manufacturer5August 21, 2014040api.fda.gov
Abiomed, Inc.Danvers, MA, United StatesComplaint file establishment, Specification developer4January 19, 2023042api.fda.gov
Biosense Webster, Inc.Irvine, CA, United StatesComplaint file establishment, Specification developer4July 25, 2017020api.fda.gov
Enablecv, LLCMidvale, UT, United StatesSpecification developer4March 6, 2014000api.fda.gov
Vygon MFGDover, NH, United StatesManufacturer4July 5, 2016000api.fda.gov
Biocardia, Inc.Sunnyvale, CA, United StatesManufacturer3August 23, 2024020api.fda.gov
CIRCA Scientific, Inc.Englewood, CO, United StatesSpecification developer3April 24, 2025000api.fda.gov
Edwards Lifesciences LLCDraper, UT, United StatesManufacturer3April 17, 2026000api.fda.gov
Surmodics, Inc.Eden Prairie, MN, United StatesComplaint file establishment, Specification developer3September 24, 2025000api.fda.gov
Vygon UsaLansdale, PA, United StatesSpecification developer3July 5, 2016000api.fda.gov
W. L. Gore & Associates, Inc.Phoenix, AZ, United StatesComplaint file establishment, Specification developer3July 21, 2016010api.fda.gov
Angiodynamics, Inc.Queensbury, NY, United StatesManufacturer2July 19, 2017010api.fda.gov
AngioDynamics, Inc.Marlborough, MA, United StatesSpecification developer2July 19, 2017000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer2June 20, 2003010api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesManufacturer2March 20, 2025021api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer2May 20, 2019000api.fda.gov
Covidien LLCMansfield, MA, United StatesSpecification developer2October 7, 1987000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesContract manufacturer, Manufacturer2June 20, 2003000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer2July 25, 2019000api.fda.gov
Insitu Technologies, Inc.Saint Paul, MN, United StatesSpecification developer2February 9, 2005000api.fda.gov
Inari Medical, Inc.Irvine, CA, United StatesManufacturer2December 12, 2023000api.fda.gov
Mozarc Medical Us LLCMansfield, MA, United StatesSpecification developer2October 7, 1987000api.fda.gov
Medtronic VascularSanta Rosa, CA, United StatesSpecification developer2December 20, 2017000api.fda.gov
Nova Vascular LLCNew York, NY, United StatesSpecification developer2October 21, 2025000api.fda.gov
RLS Interventional Inc. DBA InradGrand Rapids, MI, United StatesManufacturer2November 16, 1981000api.fda.gov
Synaptic Medical CorporationCarlsbad, CA, United StatesComplaint file establishment, Manufacturer2February 16, 2024000api.fda.gov
Teleflex LLCBrooklyn Park, MN, United StatesManufacturer2May 9, 2018000api.fda.gov
Vascular Solutions LLCMaple Grove, MN, United StatesManufacturer, Repackager or relabeler, Specification developer2May 9, 2018000api.fda.gov
Vizaramed, Inc.San Jose, CA, United StatesComplaint file establishment, Specification developer2March 26, 2026000api.fda.gov
Abbott MedicalMinnetonka, MN, United StatesManufacturer1July 27, 2021000api.fda.gov
Abbott VascularTemecula, CA, United StatesComplaint file establishment, Specification developer1April 13, 1994000api.fda.gov
Abbott VascularSanta Clara, CA, United StatesSpecification developer1April 13, 1994000api.fda.gov
AtriCure, Inc.Pleasanton, CA, United StatesSpecification developer1February 13, 2024000api.fda.gov
Becton Dickinson Infusion Therapy Systems Inc.Sandy, UT, United StatesManufacturer, Specification developer1June 12, 2002010api.fda.gov
Carefusion 2200, Inc.Vernon Hills, IL, United StatesComplaint file establishment, Specification developer1June 12, 2002000api.fda.gov
Centurion Medical Products, LPWilliamston, MI, United StatesSpecification developer1August 9, 1989000api.fda.gov
Centurion Medical Products, LPHowell, MI, United StatesManufacturer1August 9, 1989000api.fda.gov
Cook Medical LLCBloomington, IN, United StatesComplaint file establishment, Contract manufacturer1April 17, 2014000api.fda.gov
Cultiv8 1, LLCMinneapolis, MN, United StatesComplaint file establishment, Specification developer1January 22, 2026000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer1October 6, 1992000api.fda.gov
Curatia Medical Co.Sunnyvale, CA, United StatesSpecification developer1April 27, 2022000api.fda.gov
Eosolutions, Corp.Miramar, FL, United StatesComplaint file establishment, Specification developer1September 27, 2023000api.fda.gov
Endologix LLCSanta Rosa, CA, United StatesComplaint file establishment, Specification developer1February 9, 2012000api.fda.gov
Endologix LLCIrvine, CA, United StatesManufacturer1February 9, 2012000api.fda.gov
Footprint Medical Inc.San Antonio, TX, United StatesManufacturer1February 24, 2010000api.fda.gov
Freudenberg Medical, LLCJeffersonville, IN, United StatesComplaint file establishment, Contract manufacturer, Manufacturer1May 30, 2019010api.fda.gov
Hartman Medical Group,LLCBirmingham, AL, United StatesComplaint file establishment, Specification developer1July 6, 2026000api.fda.gov
Inquis Medical, Inc.Menlo Park, CA, United StatesManufacturer1April 13, 2026000api.fda.gov
Numed, Inc.Hopkinton, NY, United StatesManufacturer1October 20, 2017000api.fda.gov
Penumbra, Inc.Alameda, CA, United StatesManufacturer1November 20, 2024000api.fda.gov
Pressure Products Medical Device Manufacturing LLCMorton, PA, United StatesManufacturer1October 26, 2018000api.fda.gov
Protaryx Medical, LLCBaltimore, MD, United StatesManufacturer1April 10, 2026000api.fda.gov
Penumbra Inc.Roseville, CA, United StatesManufacturer1November 20, 2024000api.fda.gov
Penumbra Inc.Salt Lake City, UT, United StatesManufacturer1November 20, 2024000api.fda.gov
Penumbra Inc.Livermore, CA, United StatesManufacturer1November 20, 2024000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesManufacturer, Repackager or relabeler1November 9, 1993000api.fda.gov
Respicardia, Inc.Minnetonka, MN, United StatesComplaint file establishment, Specification developer1April 6, 2026000api.fda.gov
South53San Juan Capistrano, CA, United StatesManufacturer1September 29, 2025000api.fda.gov
Spectra Medical Devices, LLCWilmington, MA, United StatesManufacturer1December 8, 2008000api.fda.gov
Surmodics, Inc.Eden Prairie, MN, United StatesSpecification developer1April 18, 2019000api.fda.gov
Stryker Sustainability SolutionsTempe, AZ, United StatesSpecification developer1January 24, 2013000api.fda.gov
Stryker Sustainability Solutions PhoenixPhoenix, AZ, United StatesReprocessor1January 24, 2013000api.fda.gov
Vascutech Medical, LLCOaks, PA, United StatesManufacturer1February 9, 2026000api.fda.gov
ev3, Inc.Plymouth, MN, United StatesManufacturer1November 8, 1991000api.fda.gov
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer0000api.fda.gov
B. Braun Us Device Manufacturing LLCAllentown, PA, United StatesContract manufacturer, Contract sterilizer0040api.fda.gov
BiomericsSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesContract sterilizer, Specification developer0000api.fda.gov
Cardiofocus, Inc.Marlborough, MA, United StatesManufacturer, Specification developer0000api.fda.gov
Carefusion 2200, Inc.Mannford, OK, United StatesContract manufacturer0000api.fda.gov
CPE1, LLC DBA Greatbatch MedicalSouthwest Ranches, FL, United StatesContract manufacturer0000api.fda.gov
Cirtec MedicalSanta Clara, CA, United StatesContract manufacturer0000api.fda.gov
EPIC MedTec OEM Catheter & Wire LLCPlymouth, MN, United StatesContract manufacturer0000api.fda.gov
EPIC MedTec OEM LLCJaffrey, NH, United StatesContract manufacturer0000api.fda.gov
Goodwill Commercial ServicesIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Hart Enterprises, Inc.Sparta, MI, United StatesContract manufacturer0000api.fda.gov
Innovative Health, LLC.Scottsdale, AZ, United StatesReprocessor0000api.fda.gov
Irvine Biomedical. Inc.Irvine, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Isomedix Operations Inc.Northborough, MA, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Isomedix Operations Inc.S Plainfield, NJ, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
LightningcathBrooklyn Park, MN, United StatesContract manufacturer0000api.fda.gov
Martech Medical ProductsHarleysville, PA, United StatesContract manufacturer0000api.fda.gov
Medron, LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Merit Medical Systems, Inc.Houston, TX, United StatesContract manufacturer0090api.fda.gov
NeedleTech Products, Inc.N Attleboro, MA, United StatesContract manufacturer0000api.fda.gov
Nypro Inc (Maple Grove)Maple Grove, MN, United StatesContract manufacturer0000api.fda.gov
PDV MedTechMorgan Hill, CA, United StatesContract manufacturer0000api.fda.gov
Sterilization Services Of VirginiaRichmond, VA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Switchback MedicalBrooklyn Park, MN, United StatesContract manufacturer0000api.fda.gov
Stryker NeurovascularFremont, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Terumo BCT STERILIZATION SERVICES, Inc.Lakewood, CO, United StatesContract manufacturer, Contract sterilizer0000api.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.