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

FDA-registered makers of Endoscopic Video Imaging System/Component, Gastroenterology-Urology in the United States: 18 establishments

18 establishments in the United States are registered with the FDA to make Endoscopic Video Imaging System/Component, Gastroenterology-Urology (product code FET). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.

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Device
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Product code
FET
Country
United States

Makers of Endoscopic Video Imaging System/Component, Gastroenterology-Urology in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Karl Storz Endoscopy-America, Inc.Auburn, MA, United StatesContract manufacturer, Repackager or relabeler15September 1, 2020000api.fda.gov
Linvatec CorporationLargo, FL, United StatesSpecification developer4June 20, 2008000api.fda.gov
Clarus Medical, LLC.Minneapolis, MN, United StatesManufacturer1September 27, 1991000api.fda.gov
Medtronic NeurosurgeryFort Worth, TX, United StatesSpecification developer1September 27, 1991000api.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
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer0000api.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
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesSpecification developer0000api.fda.gov
Karl Storz Imaging, Inc.Goleta, CA, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
Life Science Logistics, LLCBrownsburg, IN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Mclean Medical & ScientificSaint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Neptune Medical, IncBurlingame, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Tangent Endoscopy, LLCCamden, DE, United StatesSpecification developer0000api.fda.gov

Updated November 3, 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.