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Data / Medical devices / Illuminator, Fiberoptic, Surgical Field

Illuminator, Fiberoptic, Surgical Field (HBI): 14 FDA-registered makers in 4 countries

14 establishments in 4 countries are registered with the FDA to make Illuminator, Fiberoptic, Surgical Field (product code HBI, Class 2, 21 CFR 878.4580). 9 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 28 510(k) clearances under this code, the latest on January 13, 2023, and lists 0 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
HBI
Device class
2
Regulation
878.4580
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States11
Germany1
Mexico1
Czechia1

Makers of Illuminator, Fiberoptic, Surgical Field

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
Bausch & Lomb IncorporatedSaint Louis, MO, United StatesManufacturer2April 19, 1991000api.fda.gov
Olympus Winter & Ibe GMBHHamburg, GermanyComplaint file establishment, Exporter to the US, Specification developer2January 13, 2023000api.fda.gov
CovidienTIJUANA, B.C. Mexico, MexicoManufacturer1September 26, 1988000api.fda.gov
CovidienNorth Haven, CT, United StatesSpecification developer1September 26, 1988000api.fda.gov
Gulf Fiberoptics, Inc.Oldsmar, FL, United StatesManufacturer1September 6, 2002000api.fda.gov
Katalyst Surgical, LLCChesterfield, MO, United StatesComplaint file establishment, Manufacturer, Specification developer1April 9, 2015000api.fda.gov
Medical Illumination International, IncChatsworth, CA, United StatesManufacturer1November 21, 2016000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1March 23, 1992000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer1March 23, 1992000api.fda.gov
Nico CorporationIndianapolis, IN, United StatesSpecification developer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
Schott CR, S.R.O.Valasske Mezirici Zlinsky Kraj, CzechiaContract manufacturer0000api.fda.gov
Sunoptic Technologies, LLCJacksonville, FL, United StatesContract manufacturer, Manufacturer0000api.fda.gov

Updated January 13, 2023. 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.