Skip to the page
Get started – free

Data / Medical devices / Instrument, Special Lens, For Endoscope

Instrument, Special Lens, For Endoscope (FEI): 19 FDA-registered makers in 6 countries

19 establishments in 6 countries are registered with the FDA to make Instrument, Special Lens, For Endoscope (product code FEI, Class 1, 21 CFR 876.1500). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on January 14, 1988, 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
FEI
Device class
1
Regulation
876.1500
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States10
Germany5
China1
Costa Rica1
Pakistan1
Czechia1

Makers of Instrument, Special Lens, For Endoscope

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
Access OpticsBroken Arrow, OK, United StatesContract manufacturer0000api.fda.gov
Ari Medical Technology Co., Ltd.Hefei Anhui, ChinaManufacturer0000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer0000api.fda.gov
Arthrex California Technology, IncorporatedSanta Barbara, CA, United StatesContract manufacturer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrocare CorporationCoyol Alajuela, Costa RicaManufacturer0000api.fda.gov
Eurofins STERIPAC GMBHCalw-Altburg Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Heinrich Medizintechnik GMBHStuttgart Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Novanta Medical S.R.O.Prelouc Pardubicky Kraj, CzechiaManufacturer0000api.fda.gov
Novanta Medical GmbHLUDWIGSSTADT Bavaria, GermanyManufacturer0000api.fda.gov
Novanta Medical GmbHBerlin, GermanySpecification developer0000api.fda.gov
Ovesco Endoscopy AGTuebingen Baden-Wurttemberg, GermanyManufacturer, Specification developer0000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer0000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer0000api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer0000api.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 January 14, 1988. 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.