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Data / Medical devices / Instrument, Ent Manual Surgical / United States

FDA-registered makers of Instrument, Ent Manual Surgical in the United States: 47 establishments

47 establishments in the United States are registered with the FDA to make Instrument, Ent Manual Surgical (product code LRC). 8 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.

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Device
Instrument, Ent Manual Surgical
Product code
LRC
Country
United States

Makers of Instrument, Ent Manual Surgical in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Acclarent, Inc.Irvine, CA, United StatesSpecification developer8August 27, 2020010api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer4November 20, 2015000api.fda.gov
Intuit Medical Products, LLCLawrenceville, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer2January 3, 2020000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer2December 1, 2015000api.fda.gov
ExcelentDurham, NC, United StatesComplaint file establishment, Specification developer1May 25, 2023000api.fda.gov
Freudenberg Medical, LLCCarpinteria, CA, United StatesManufacturer1December 17, 2013000api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer1March 23, 1994000api.fda.gov
RG Medical USAMount Juliet, TN, United StatesRepackager or relabeler, Specification developer1March 23, 1994000api.fda.gov
Airiver MedicalBrooklyn Park, MN, United StatesManufacturer0000api.fda.gov
Atrion Medical Products, Inc.Arab, AL, United StatesContract manufacturer0000api.fda.gov
Biomerics FmiAthens, TX, United StatesContract manufacturer0000api.fda.gov
Boston Medical Products, Inc.Shrewsbury, MA, United StatesManufacturer0000api.fda.gov
Classic Wire Cut Company, Inc.Valencia, CA, United StatesContract manufacturer0000api.fda.gov
Corit Medical LLCMcLean, VA, United StatesManufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Dalent MedicalMiami, FL, United StatesManufacturer0000api.fda.gov
Ear Technology CorporationJohnson City, TN, United StatesSpecification developer0000api.fda.gov
Elmed, Inc.Glendale Heights, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Fiagon NA LLCSaint Paul, MN, United StatesManufacturer0000api.fda.gov
Grace Medical, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Gyrus Acmi, Inc.Bartlett, TN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.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
JEDMED Instrument CompanySaint Louis, MO, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer0000api.fda.gov
Logan Instruments, LLCBraintree, MA, United StatesContract manufacturer0000api.fda.gov
Mclean Medical & ScientificSaint Paul, MN, United StatesContract manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Midwest Interventional SystemsMaple Grove, MN, United StatesContract manufacturer0000api.fda.gov
Myriad Fiber Imaging Technologies, Inc.Dudley, MA, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
RHEIN PRECISION Inc.Saint Louis, MO, United StatesContract manufacturer0000api.fda.gov
Shine Medical, LLCLakeland, FL, United StatesContract manufacturer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesSpecification developer0000api.fda.gov
Stryker Corp.Kalamazoo, MI, United StatesContract manufacturer0000api.fda.gov
Suretek MedicalGreenville, SC, United StatesReprocessor0000api.fda.gov
Surgical Technologies, Inc.St. Paul, MN, United StatesContract manufacturer0000api.fda.gov
SimplicitySpanish Fork, UT, United StatesSpecification developer0000api.fda.gov
Technical Products, Inc.Buford, GA, United StatesManufacturer0000api.fda.gov
Total Titanium, Inc.Red Bud, IL, United StatesContract manufacturer, Manufacturer0000api.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
WM&DGNorthbrook, IL, 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.