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Data / Medical devices / Bronchoscope Accessory / United States

FDA-registered makers of Bronchoscope Accessory in the United States: 18 establishments

18 establishments in the United States are registered with the FDA to make Bronchoscope Accessory (product code KTI). 13 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device
Bronchoscope Accessory
Product code
KTI
Country
United States

Makers of Bronchoscope Accessory in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Manufacturer3March 18, 2020000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer2June 23, 2017000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer2June 23, 2017000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer2March 8, 2022000api.fda.gov
Acclarent, Inc.Irvine, CA, United StatesSpecification developer1March 31, 2011020api.fda.gov
Atrion Medical Products, Inc.Arab, AL, United StatesContract manufacturer, Manufacturer1June 12, 2009000api.fda.gov
Bryan Medical Inc.Cincinnati, OH, United StatesSpecification developer1June 25, 2015010api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer1April 25, 1984000api.fda.gov
Gyrus Acmi, Inc.Westborough, MA, United StatesSpecification developer1March 18, 2020000api.fda.gov
Intuit Medical Products, LLCLawrenceville, GA, United StatesSpecification developer1July 27, 2016000api.fda.gov
Leadoptik Inc.San Jose, CA, United StatesManufacturer1December 19, 2025000api.fda.gov
Praxis Medical LLCTampa, FL, United StatesSpecification developer1September 25, 2023000api.fda.gov
Serpex Medical, Inc.Santa Clara, CA, United StatesComplaint file establishment, Specification developer1October 8, 2025000api.fda.gov
Centerpoint Systems LLCWest Valley City, UT, United StatesContract manufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesManufacturer for export0000api.fda.gov
Quadrant Technologies, LLCGrayslake, IL, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Resolution MedicalMinneapolis, MN, 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.