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Data / Medical devices / Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Endoscopic Video Imaging System/Component, Gastroenterology-Urology (FET): 68 FDA-registered makers in 16 countries

68 establishments in 16 countries are registered with the FDA to make Endoscopic Video Imaging System/Component, Gastroenterology-Urology (product code FET, Class 2, 21 CFR 876.1500). 26 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 101 510(k) clearances under this code, the latest on September 10, 2026, and lists 5 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
FET
Device class
2
Regulation
876.1500
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States18
Germany12
Japan11
China10
Ireland3
Malaysia2
Taiwan2
Canada2
France1
Mexico1
Denmark1
Costa Rica1
Israel1
Estonia1
Bulgaria1
Switzerland1

Makers of Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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
Karl Storz Endoscopy-America, Inc.Auburn, MA, United StatesContract manufacturer, Repackager or relabeler15September 1, 2020000api.fda.gov
Olympus Medical Systems Corp.HACHIOJI-SHI Tokyo, JapanSpecification developer12September 10, 2026000api.fda.gov
Shirakawa Olympus Co., Ltd.NISHISHIRAKAWA-GUN Fukushima, JapanManufacturer12September 10, 2026000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer11May 13, 2022000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer6June 14, 2022000api.fda.gov
Linvatec CorporationLargo, FL, United StatesSpecification developer4June 20, 2008000api.fda.gov
Aizu Olympus Co., Ltd.AIZUWAKAMATSU-SHI Fukushima, JapanManufacturer2April 26, 2023010api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Sano OfficeSano City Tochigi, JapanManufacturer2July 2, 2026000api.fda.gov
SoproLA CIOTAT CEDEX Bouches-du-Rhone, FranceManufacturer2December 3, 1997000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer1June 17, 1994000api.fda.gov
Clarus Medical, LLC.Minneapolis, MN, United StatesManufacturer1September 27, 1991000api.fda.gov
Consolidated Medical Equipment CompanyChihuahua, MexicoManufacturer1June 20, 2008000api.fda.gov
Fujifilm CorporationASHIGARAKAMI-GUN Kanagawa, JapanSpecification developer1July 2, 2026000api.fda.gov
FUJIFILM Corporation Medical Systems Research & Development Center KaiseiAshigarakami-Gun Kanagawa, JapanContract manufacturer, Manufacturer, Specification developer1April 11, 2025000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Hanamaki OfficeHANAMAKI-SHI Iwate, JapanManufacturer1July 2, 2026000api.fda.gov
Guangzhou Red Pine Medical Instrument Co.,ltd.Guangzhou Guangdong, ChinaManufacturer1February 7, 2025000api.fda.gov
HOYA Corporation PENTAX Lifecare DivisionAkishima-shi Tokyo, JapanComplaint file establishment, Specification developer1February 7, 1994000api.fda.gov
Medtronic NeurosurgeryFort Worth, TX, United StatesSpecification developer1September 27, 1991000api.fda.gov
Proverum LimitedGalway Galway(County), IrelandManufacturer1September 24, 2025000api.fda.gov
Proverum LimitedDUBLIN 1 Dublin(County), IrelandSpecification developer1September 24, 2025000api.fda.gov
Shanghai Seegen Photoelectric Technology Co., LtdShanghai, ChinaManufacturer1October 22, 2024000api.fda.gov
Shanghai Seegen Photoelectric Technology Co., LtdShanghai, ChinaManufacturer1October 22, 2024000api.fda.gov
Shenzhen Sophway Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer1July 1, 2025000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer1February 2, 2001000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesSpecification developer1April 1, 1982000api.fda.gov
Zhuhai Pusen Medical Technology Co., Ltd.Zhuhai Guangdong, ChinaManufacturer1March 29, 2019000api.fda.gov
Ambu Innovation GMBHAugsburg Bavaria, GermanySpecification developer0000api.fda.gov
Ambu SDN.BHD.PENANG Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Ambu A/SBallerup Hovedstaden, DenmarkSpecification developer0000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Britemed Technology Inc.New Taipei City, TaiwanContract manufacturer0000api.fda.gov
Boston Scientific CorporationEl Coyol Alajuela, Costa RicaManufacturer0000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer0000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer0000api.fda.gov
Centerpoint Systems LLCWest Valley City, UT, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cordica Medical, Inc.Sunrise, FL, United StatesContract manufacturer0000api.fda.gov
Enercon TechnologiesGray, ME, United StatesContract manufacturer0000api.fda.gov
Evoendo, Inc.Grayslake, IL, United StatesSpecification developer0000api.fda.gov
Gi View Ltd.Ramat Gan Central, IsraelManufacturer0000api.fda.gov
Henke-Sass Wolf, GMBH.TUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
HOYA Corporation PENTAX Lifecare DivisionKURIHARA-SHI Miyagi, JapanExporter to the US, Manufacturer0000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesSpecification developer0000api.fda.gov
Karl Storz Imaging, Inc.Goleta, CA, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Video Endoscopy Estonia OueLaagri Harjumaa, EstoniaContract manufacturer0000api.fda.gov
Life Science Logistics, LLCBrownsburg, IN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
MCD Medical Computers Deutschland GmbHHuellhorst North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Mclean Medical & ScientificSaint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.Nanjing Jiangsu, ChinaManufacturer0000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.NAN JING Jiangsu, ChinaManufacturer0000api.fda.gov
Neptune Medical, IncBurlingame, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
OLYMPUS MEDICAL SYSTEMS CORP. Hinode PlantNISHITAMA-GUN Tokyo, JapanManufacturer0000api.fda.gov
Olympus Winter & Ibe GMBHHamburg, GermanyManufacturer0000api.fda.gov
Opcom Medical Inc.New Taipei City, TaiwanManufacturer0000api.fda.gov
Plexus Manufacturing Sdn.Bhd.Bayan Lepas Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Qisda Electronics (suzhou) Co., Ltd.Suzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Rudolf Medical GMBH + Co. KGFRIDINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Schoelly Fiberoptic, GMBHDENZLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Schoelly-Optix OodPanagyurishte Pazardzhik, BulgariaContract manufacturer0000api.fda.gov
Scivita Medical Technology Co., Ltd.suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Shenzhen Hugemed Medical Technical Development Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Steute Technologies GMBH & Co. KGLoehne North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Storz Endoskop Produktions GMBHSchaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
Sony CorporationYokohama-shi Kanagawa, JapanComplaint file establishment, Specification developer0000api.fda.gov
Tangent Endoscopy, LLCCamden, DE, United StatesSpecification developer0000api.fda.gov
Verathon Medical (canada) ULCBurnaby British Columbia, CanadaSpecification developer0000api.fda.gov
Verathon Medical (canada) ULC.BURNABY British Columbia, CanadaManufacturer0000api.fda.gov

Updated September 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.