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Data / Medical devices / Gag, Mouth / United States

FDA-registered makers of Gag, Mouth in the United States: 24 establishments

24 establishments in the United States are registered with the FDA to make Gag, Mouth (product code KBN). 0 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
Gag, Mouth
Product code
KBN
Country
United States

Makers of Gag, Mouth in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Arnold Tuber IndustriesOrchard Park, NY, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Cislak Manufacturing, Inc.Niles, IL, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Fetzer Surgical, LLCScottsdale, AZ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Flexbar Machine Corp.Islandia, NY, United StatesManufacturer0000api.fda.gov
Fischer Surgical Inc.Imperial, MO, United StatesManufacturer0000api.fda.gov
Gsource, LLC.Emerson, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
H & H Co.Hayden, ID, United StatesContract manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Hu-Friedy MFG. Co. LLCNorthbrook, IL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
J & J Instruments, LLCNorthbrook, IL, United StatesSpecification developer0000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
One DashcorpSylmar, CA, United StatesRemanufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Princeton Medical Group, Inc.Franklin, TN, United StatesSpecification developer0000api.fda.gov
Power Dental USA, Inc.McHenry, IL, United StatesManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Specialized Care Co IncHampton, NH, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesSpecification developer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Weco Manufacturing Group-HenriettaRochester, NY, United StatesManufacturer, Repackager or relabeler0000api.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.