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Data / Medical devices / Stents, Drains And Dilators For The Biliary Ducts / United States

FDA-registered makers of Stents, Drains And Dilators For The Biliary Ducts in the United States: 46 establishments

46 establishments in the United States are registered with the FDA to make Stents, Drains And Dilators For The Biliary Ducts (product code FGE). 37 have a 510(k) clearance or PMA approval on file and 14 have a recall event. FDA data exported November 3, 2026.

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Device
Stents, Drains And Dilators For The Biliary Ducts
Product code
FGE
Country
United States

Makers of Stents, Drains And Dilators For The Biliary Ducts in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Boston Scientific CorporationCoventry, RI, United StatesManufacturer, Manufacturer for export23July 3, 2025000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer19July 3, 20250110api.fda.gov
Cordis US Corp.Miami Lakes, FL, United StatesComplaint file establishment, Manufacturer for export, Specification developer13July 6, 2012080api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer, Manufacturer for export11May 1, 2018070api.fda.gov
Cook Medical LLCBloomington, IN, United StatesComplaint file establishment, Contract manufacturer10June 14, 2024010api.fda.gov
ev3, Inc.Plymouth, MN, United StatesManufacturer8March 18, 20080180api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer, Manufacturer for export7July 3, 2025020api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer4April 22, 2005000api.fda.gov
TeleMed SystemsNorthborough, MA, United StatesSpecification developer4March 1, 2002000api.fda.gov
Abbott VascularTemecula, CA, United StatesComplaint file establishment, Manufacturer3August 18, 2008020api.fda.gov
Applied Medical Resources Corp.Rsm, CA, United StatesComplaint file establishment, Manufacturer3March 28, 1991010api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesContract manufacturer, Manufacturer3January 24, 2008000api.fda.gov
Applied Medical Distribution CenterIrvine, CA, United StatesManufacturer3March 28, 1991000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer3August 22, 2014030api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Manufacturer3March 8, 2018000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer, Specification developer3March 14, 2019030api.fda.gov
W. L. Gore & Associates, Inc.Elkton, MD, United StatesManufacturer3May 8, 2017020api.fda.gov
Abbott VascularSanta Clara, CA, United StatesSpecification developer2August 18, 2008000api.fda.gov
Angiodynamics, Inc.Queensbury, NY, United StatesManufacturer2March 30, 2017000api.fda.gov
AngioDynamics, Inc.Marlborough, MA, United StatesSpecification developer2March 30, 2017000api.fda.gov
Q3 Medical Usa, LLCCharlotte, NC, United StatesComplaint file establishment, Manufacturer2July 27, 2026000api.fda.gov
Wilson-Cook Medical Inc.Winston Salem, NC, United StatesComplaint file establishment, Manufacturer2October 13, 20170100api.fda.gov
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer, Manufacturer1May 23, 1996000api.fda.gov
Arrow International LLC (subsidiary of Teleflex Incorporated)Morrisville, NC, United StatesComplaint file establishment, Specification developer1January 18, 1991000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex, Incorporated)Chelmsford, MA, United StatesManufacturer1January 18, 1991000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer1February 13, 1991000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesManufacturer1October 12, 2016060api.fda.gov
Bard Access Systems, Inc.Salt Lake City, UT, United StatesSpecification developer1November 7, 1996000api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer1November 24, 1992000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer1February 13, 1991000api.fda.gov
Endofix Medical TechnologiesPlainville, MA, United StatesSpecification developer1August 20, 2025000api.fda.gov
Gie MedicalBrooklyn Park, MN, United StatesManufacturer1March 13, 2026000api.fda.gov
Gyrus Acmi, Inc.Westborough, MA, United StatesSpecification developer1March 8, 2018000api.fda.gov
Hobbs Medical, Inc.Stafford Springs, CT, United StatesManufacturer1March 22, 1984010api.fda.gov
Lucas Medical, Inc.Orange, CA, United StatesManufacturer1May 10, 1996000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer1January 18, 1991000api.fda.gov
Uresil, LLCSkokie, IL, United StatesManufacturer1July 13, 1993000api.fda.gov
Admedes Inc.Livermore, CA, United StatesContract manufacturer0000api.fda.gov
Allwin Medical Devices, Inc.Anaheim, CA, United StatesManufacturer for export0000api.fda.gov
Burpee Materials Technology, LLCEatontown, NJ, United StatesContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
Cook IncorporatedEllettsville, IN, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Harmac Medical Products, Inc.Buffalo, NY, United StatesContract manufacturer0000api.fda.gov
Lake Region MedicalChaska, MN, United StatesSpecification developer0000api.fda.gov
Norman Noble, Inc.Highland Heights, OH, United StatesContract manufacturer0000api.fda.gov
Sage Product Development, Inc.Foxborough, MA, 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.