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Data / Medical devices / Speculum, Ent / United States

FDA-registered makers of Speculum, Ent in the United States: 37 establishments

37 establishments in the United States are registered with the FDA to make Speculum, Ent (product code EPY). 0 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

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Device
Speculum, Ent
Product code
EPY
Country
United States

Makers of Speculum, Ent in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Alira Medical Devices LLCRancho Cucamonga, CA, United StatesSpecification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Bear-Ent, LLCMalvern, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Bionix, LLCMaumee, OH, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Black & Black Surgical, Inc.Tucker, GA, United StatesSpecification developer0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Centurion Medical Products, LPWilliamston, MI, United StatesSpecification developer0000api.fda.gov
Fetzer Surgical, LLCScottsdale, AZ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Firefly GlobalBelmont, MA, United StatesManufacturer0000api.fda.gov
Fischer Surgical Inc.Imperial, MO, 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
H & H Co.Hayden, ID, United StatesContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
Holger Bumueller LLCRutherfordton, NC, 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
J & J Instruments, LLCNorthbrook, IL, United StatesSpecification developer0000api.fda.gov
Katena Products, Inc.Parsippany, NJ, United StatesSpecification developer0000api.fda.gov
Katena Products, Inc.Randolph, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer0000api.fda.gov
Mclean Medical & ScientificSaint Paul, MN, United StatesContract manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - LaredoLaredo, TX, United StatesManufacturer, Repackager or relabeler, Reprocessor0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0010api.fda.gov
Mizuho America, Inc.Union City, CA, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
National Advanced Endoscopy Devices, Inc.Canoga Park, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Pilotis Tech LLCBrookhaven, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Princeton Medical Group, Inc.Franklin, TN, United StatesSpecification developer0000api.fda.gov
RC Consolidated Services, IncRancho Cucamonga, CA, United StatesSpecification developer0000api.fda.gov
RSB Spine LLC.Wooster, OH, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Scanlan International, Inc.Saint Paul, MN, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesSpecification developer0000api.fda.gov
Trademark Plastics Inc.Riverside, CA, 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

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.