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Data / Medical devices / Splint, Intranasal Septal / United States

FDA-registered makers of Splint, Intranasal Septal in the United States: 36 establishments

36 establishments in the United States are registered with the FDA to make Splint, Intranasal Septal (product code LYA). 11 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.

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Device
Splint, Intranasal Septal
Product code
LYA
Country
United States

Makers of Splint, Intranasal Septal in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Boston Medical Products, Inc.Shrewsbury, MA, United StatesContract manufacturer, Manufacturer4July 15, 1997000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer4October 23, 2014000api.fda.gov
SPIWay, LLCCarlsbad, CA, United StatesSpecification developer3October 27, 2021000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer, Specification developer2December 8, 2020000api.fda.gov
ArthroCare CorporationAustin, TX, United StatesSpecification developer1June 16, 2014000api.fda.gov
Biomed Ent, IncMilwaukee, WI, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1March 22, 2023000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Manufacturer, Specification developer1November 30, 2018000api.fda.gov
Hemostasis, LLCSaint Paul, MN, United StatesManufacturer1March 27, 2013000api.fda.gov
Spirair, IncSouth San Francisco, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1July 11, 2025000api.fda.gov
SpirairMountain View, CA, United StatesManufacturer1July 11, 2025000api.fda.gov
Westmed, Inc.Tucson, AZ, United StatesManufacturer1January 15, 1993000api.fda.gov
Chitogen IncMaple Grove, MN, United StatesManufacturer, Specification developer0000api.fda.gov
CoagSaint Paul, MN, United StatesManufacturer0000api.fda.gov
Davol Inc.Woburn, MA, United StatesManufacturer0000api.fda.gov
Davol Inc., Sub. C.R. Bard, Inc.Warwick, RI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Endure Industries, Inc.Homer, NY, United StatesSpecification developer0000api.fda.gov
Fmi LLCLincolnshire, IL, United StatesContract manufacturer0000api.fda.gov
Gyrus Acmi, Inc.Bartlett, TN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Invotec International, Inc.Jacksonville, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
InnovizeNorth Oaks, MN, United StatesContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer0000api.fda.gov
Medtronic Xomed, Inc.Mystic, CT, United StatesManufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Mueller Sports Medicine, Inc.Prairie Du Sac, WI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
NasaClip Inc.Baltimore, MD, United StatesSpecification developer0000api.fda.gov
Orca Products LLCDothan, AL, United StatesSpecification developer0000api.fda.gov
PS Devices, LLCLyndhurst, OH, United StatesSpecification developer0000api.fda.gov
Quality Bioresources, IncSeguin, TX, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Summit Medical LLCSaint Paul, MN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Surgical Technologies, Inc.St. Paul, MN, United StatesContract manufacturer0000api.fda.gov
Trelleborg Sealing Solutions Us, Inc.Paso Robles, CA, United StatesContract manufacturer0000api.fda.gov
Trelleborg Sealing Solutions US, Inc.Tustin, CA, United StatesContract manufacturer0000api.fda.gov
Tricol Biomedical, INC.Portland, OR, United StatesSpecification developer0000api.fda.gov
Welly Health PBCMinneapolis, MN, United StatesSpecification developer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesContract manufacturer0000api.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.