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Data / Medical devices / Tube, Tympanostomy

Tube, Tympanostomy (ETD): 19 FDA-registered makers in 7 countries

19 establishments in 7 countries are registered with the FDA to make Tube, Tympanostomy (product code ETD, Class 2, 21 CFR 874.3880). 13 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 116 510(k) clearances under this code, the latest on April 23, 2026, and lists 7 recall events (0 Class I). 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 every maker of this deviceMakers in the United StatesWatch this device
Product code
ETD
Device class
2
Regulation
874.3880
Medical specialty
Ear, Nose, Throat
Implant
Yes

Makers by country

CountryMakers
United States11
Ireland2
Germany2
United Kingdom1
New Zealand1
Costa Rica1
Dominican Republic1

Makers of Tube, Tympanostomy

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Specification developer7June 19, 2000000api.fda.gov
Grace Medical, Inc.Memphis, TN, United StatesManufacturer6November 24, 2023000api.fda.gov
Gyrus Acmi, Inc.Bartlett, TN, United StatesManufacturer, Repackager or relabeler6June 19, 2000000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer5July 22, 2015000api.fda.gov
Exmoor Plastics LimitedChorley Lancashire, United KingdomManufacturer3May 5, 1993000api.fda.gov
Aventamed DacBishopstown Cork(City), IrelandComplaint file establishment, Specification developer2April 28, 2025000api.fda.gov
Heinz Kurz GMBH MedizintechnikDUSSLINGEN Baden-Wurttemberg, GermanyManufacturer2December 12, 2007000api.fda.gov
Preceptis Medical, IncGolden Valley, MN, United StatesManufacturer, Specification developer2July 27, 2022000api.fda.gov
Summit Medical LLCSaint Paul, MN, United StatesContract manufacturer, Manufacturer2August 26, 1999010api.fda.gov
Adept Medical LtdAuckland, New ZealandManufacturer1July 12, 2006010api.fda.gov
Biowy CorporationLake Forest, CA, United StatesManufacturer1February 16, 2024000api.fda.gov
Invotec International, Inc.Jacksonville, FL, United StatesManufacturer1September 26, 1990000api.fda.gov
Tusker Medical Inc.Austin, TX, United StatesSpecification developer1April 23, 2026000api.fda.gov
Arrotek Medical LtdCo. Sligo Connaught, IrelandContract manufacturer0000api.fda.gov
Biomerics AlajuelaAlajuela, Costa RicaContract manufacturer0000api.fda.gov
Covidien- Santo Domingo, Dominican RepublicContract manufacturer0000api.fda.gov
Eurofins STERIPAC GMBHCalw-Altburg Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Nissha Medical Technologies (Ohio), Inc.Norwalk, OH, United StatesContract manufacturer0000api.fda.gov
Resolution MedicalMinneapolis, MN, United StatesContract manufacturer0000api.fda.gov

Updated April 23, 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.