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Data / Medical devices / Stent, Ureteral / United States

FDA-registered makers of Stent, Ureteral in the United States: 20 establishments

20 establishments in the United States are registered with the FDA to make Stent, Ureteral (product code FAD). 14 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.

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Device
Stent, Ureteral
Product code
FAD
Country
United States

Makers of Stent, Ureteral in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer, Manufacturer for export13April 23, 2019030api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer13April 23, 2019050api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer8March 25, 1996000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer5April 15, 2025000api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesContract sterilizer, Specification developer4December 7, 2004020api.fda.gov
Applied Medical Resources Corp.Rsm, CA, United StatesComplaint file establishment, Manufacturer3March 29, 2006010api.fda.gov
Applied Medical Distribution CenterIrvine, CA, United StatesManufacturer3March 29, 2006000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesSpecification developer3April 15, 2025010api.fda.gov
The Ureteral Stent Company, Inc.Beachwood, OH, United StatesSpecification developer2March 22, 2024000api.fda.gov
Allwin Medical Devices, Inc.Anaheim, CA, United StatesManufacturer1December 2, 2019000api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer1April 15, 2025010api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer1April 15, 2025000api.fda.gov
Dornier Medtech America, Inc.Kennesaw, GA, United StatesSpecification developer1November 15, 2019000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesSpecification developer1November 22, 2016000api.fda.gov
Biomerics FmiAthens, TX, United StatesContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
EPIC MedTec OEM Catheter & Wire LLCPlymouth, MN, United StatesContract manufacturer0000api.fda.gov
Lake Region MedicalChaska, MN, United StatesSpecification developer0000api.fda.gov
Martech Medical ProductsHarleysville, PA, United StatesContract manufacturer0000api.fda.gov
Medical Murray, Inc.Lake Zurich, IL, United StatesContract manufacturer0000api.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.