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Data / Medical devices / Endoilluminator

Endoilluminator (MPA): 17 FDA-registered makers in 4 countries

17 establishments in 4 countries are registered with the FDA to make Endoilluminator (product code MPA, Class 2, 21 CFR 876.1500). 12 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 41 510(k) clearances under this code, the latest on August 10, 2026, and lists 1 recall event (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
MPA
Device class
2
Regulation
876.1500
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States12
Netherlands2
South Korea2
Mexico1

Makers of Endoilluminator

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
Peregrine Surgical, LLC.New Britain, PA, United StatesManufacturer5August 5, 2024000api.fda.gov
Bausch & Lomb IncorporatedRochester, NY, United StatesComplaint file establishment, Specification developer3September 11, 2015000api.fda.gov
Nova Eye Inc.Fremont, CA, United StatesManufacturer3March 30, 2023000api.fda.gov
Synergetics, Inc.O Fallon, MO, United StatesManufacturer3January 5, 1996000api.fda.gov
Bausch & Lomb IncorporatedSaint Louis, MO, United StatesManufacturer, Specification developer2May 19, 1998000api.fda.gov
Alcon Research, LLCSinking Spring, PA, United StatesManufacturer1December 4, 2024000api.fda.gov
Alcon Research, LLCLake Forest, CA, United StatesSpecification developer1December 4, 2024000api.fda.gov
Alcon Research, LLCHouston, TX, United StatesManufacturer1December 4, 2024000api.fda.gov
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.ZUIDLAND Zuid-Holland, NetherlandsComplaint file establishment, Manufacturer1October 13, 2006000api.fda.gov
Iridex CorporationSan Jose, CA, United StatesManufacturer1May 20, 1997000api.fda.gov
Iridex CorporationMountain View, CA, United StatesManufacturer1May 20, 1997000api.fda.gov
Oculight Co.,Ltd.Seongnam, South KoreaManufacturer1August 20, 2021000api.fda.gov
HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Katalyst Surgical, LLCChesterfield, MO, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Shina Corp.GONGJU-SI Chungnam, South KoreaContract manufacturer0000api.fda.gov
Vitreq BVVierpolders Zuid-Holland, NetherlandsManufacturer0000api.fda.gov
Vortex Surgical, Inc.Saint Charles, MO, United StatesManufacturer0000api.fda.gov

Updated August 10, 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.