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Data / Medical devices / Cuff, Tracheal Tube, Inflatable / United States

FDA-registered makers of Cuff, Tracheal Tube, Inflatable in the United States: 22 establishments

22 establishments in the United States are registered with the FDA to make Cuff, Tracheal Tube, Inflatable (product code BSK). 7 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Cuff, Tracheal Tube, Inflatable
Product code
BSK
Country
United States

Makers of Cuff, Tracheal Tube, Inflatable in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer2May 8, 2015000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer1November 28, 1983000api.fda.gov
Instrumentation Industries, IncorporatedBethel Park, PA, United StatesManufacturer1December 17, 1997000api.fda.gov
Kal-Med, LLC.Kensington, CT, United StatesRepackager or relabeler, Specification developer1February 24, 2020000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1May 3, 2013000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesSpecification developer1July 22, 2011000api.fda.gov
Vortran Medical Technology 1, Inc.Sacramento, CA, United StatesManufacturer1May 25, 2018000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - SeabrookSeabrook, NH, United StatesContract manufacturer0000api.fda.gov
BD Medical DevelopmentCrown Point, IN, United StatesContract manufacturer0000api.fda.gov
Bryan Medical Inc.Cincinnati, OH, United StatesSpecification developer0000api.fda.gov
Exxelia MicropenHoneoye Falls, NY, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationOakland, NJ, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationLittle Ferry, NJ, United StatesContract manufacturer0000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Insert Molding Solutions, Inc.Cumming, GA, United StatesContract manufacturer0000api.fda.gov
Mackay Manufacturing, Inc.Spokane Valley, WA, United StatesContract manufacturer0000api.fda.gov
Nuvasive, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Quadrant Technologies, LLCGrayslake, IL, United StatesContract manufacturer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesContract manufacturer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, 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.