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Data / Medical devices / Endoscopic Injection Needle, Gastroenterology-Urology / United States

FDA-registered makers of Endoscopic Injection Needle, Gastroenterology-Urology in the United States: 21 establishments

21 establishments in the United States are registered with the FDA to make Endoscopic Injection Needle, Gastroenterology-Urology (product code FBK). 15 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 3, 2026.

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Device
Endoscopic Injection Needle, Gastroenterology-Urology
Product code
FBK
Country
United States

Makers of Endoscopic Injection Needle, Gastroenterology-Urology in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Carbon Medical Technologies, Inc.Saint Paul, MN, United StatesComplaint file establishment, Manufacturer4March 31, 2026000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer3July 28, 2017010api.fda.gov
United States Endoscopy Group, Inc.Mentor, OH, United StatesManufacturer, Repackager or relabeler3March 8, 2024010api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer2July 28, 2017000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Specification developer2August 10, 2001000api.fda.gov
Laborie Medical Technologies Corp.Portsmouth, NH, United StatesManufacturer, Specification developer2August 27, 2024010api.fda.gov
Avanos Medical, Inc.Alpharetta, GA, United StatesSpecification developer1December 21, 1989000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesSpecification developer1July 7, 2017010api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer1July 7, 2017000api.fda.gov
Endo-Therapeutics, Inc.Clearwater, FL, United StatesManufacturer1November 2, 2001000api.fda.gov
Hobbs Medical, Inc.Stafford Springs, CT, United StatesContract manufacturer, Manufacturer1February 4, 1984020api.fda.gov
TeleMed SystemsNorthborough, MA, United StatesSpecification developer1June 18, 1990000api.fda.gov
Uro-1, Inc.Greensboro, NC, United StatesManufacturer1May 3, 2018000api.fda.gov
Uroplasty, LLCMinnetonka, MN, United StatesManufacturer, Specification developer1August 3, 2012000api.fda.gov
Wilson-Cook Medical Inc.Winston Salem, NC, United StatesComplaint file establishment, Manufacturer1December 19, 2019010api.fda.gov
Allwin Medical Devices, Inc.Anaheim, CA, United StatesManufacturer for export0000api.fda.gov
Hart Enterprises, Inc.Sparta, MI, United StatesContract manufacturer0000api.fda.gov
Medron, LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Nissha Medical Technologies (Ohio), Inc.Norwalk, OH, United StatesContract manufacturer0000api.fda.gov
Sterigenics U.S., LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Uroviu CorporationLos Altos, CA, United StatesSpecification developer0000api.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.