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Data / Medical devices / Otoscope / United States

FDA-registered makers of Otoscope in the United States: 25 establishments

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

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers of this device in the United StatesWatch these makers
Device
Otoscope
Product code
ERA
Country
United States

Makers of Otoscope in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Aurality Inc.Herndon, VA, United StatesManufacturer, Specification developer0000api.fda.gov
Bear-Ent, LLCMalvern, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Blue Echo CarePortland, OR, United StatesManufacturer0000api.fda.gov
Elmed, Inc.Glendale Heights, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
EVCO Plastics-AMPDeforest, WI, United StatesContract manufacturer0000api.fda.gov
Firefly GlobalBelmont, MA, United StatesManufacturer0000api.fda.gov
Fischer MedicalWheat Ridge, CO, United StatesManufacturer, Remanufacturer0000api.fda.gov
Fondcircle Inc.Newport Beach, CA, United StatesSpecification developer0000api.fda.gov
Henke Sass Wolf Of America, Inc.Dudley, MA, United StatesContract manufacturer0000api.fda.gov
Karl Storz Endovision, Inc.Charlton, MA, United StatesContract manufacturer0000api.fda.gov
Kenvue Brands LLCSummit, NJ, United StatesSpecification developer0000api.fda.gov
Medrx, Inc.Largo, FL, United StatesManufacturer0000api.fda.gov
National Advanced Endoscopy Devices, Inc.Canoga Park, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
North American Rescue, LLC.Greer, SC, United StatesManufacturer0000api.fda.gov
Pivot - EdmLa Vista, NE, United StatesContract manufacturer0000api.fda.gov
Precision Optics Corp.Gardner, MA, United StatesContract manufacturer0000api.fda.gov
Remmie IncSeattle, WA, United StatesSpecification developer0000api.fda.gov
Syncron Ems, LLCPalm Bay, FL, United StatesContract manufacturer0000api.fda.gov
Tessy Plastics Corp.Elbridge, NY, United StatesContract manufacturer0000api.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
United SciencesAtlanta, GA, United StatesManufacturer0000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesManufacturer0000api.fda.gov
Wiscmed, LLCMiddleton, WI, United StatesManufacturer0000api.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.