Skip to the page
Get started free

Data / Medical devices / Ureteroscope And Accessories, Flexible/Rigid / United States

FDA-registered makers of Ureteroscope And Accessories, Flexible/Rigid in the United States: 23 establishments

23 establishments in the United States are registered with the FDA to make Ureteroscope And Accessories, Flexible/Rigid (product code FGB). 13 have a 510(k) clearance or PMA approval on file and 2 have a recall event. 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 makers of this device in the United StatesWatch these makers
Device
Ureteroscope And Accessories, Flexible/Rigid
Product code
FGB
Country
United States

Makers of Ureteroscope And Accessories, Flexible/Rigid in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Karl Storz Endoscopy-America, Inc.Auburn, MA, United StatesContract manufacturer, Repackager or relabeler13November 18, 2025000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesSpecification developer5August 26, 2026010api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer5August 26, 2026000api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesComplaint file establishment, Manufacturer5August 26, 2026000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer5August 26, 2026000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer5March 29, 2018000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesManufacturer, Repackager or relabeler, Specification developer3September 12, 2012000api.fda.gov
OTU Medical IncUnion City, CA, United StatesManufacturer, Specification developer2July 22, 2021000api.fda.gov
Auris Health, IncSanta Clara, CA, United StatesSpecification developer1April 29, 2022010api.fda.gov
Auris Health, Inc.San Jose, CA, United StatesManufacturer1April 29, 2022000api.fda.gov
Centerpoint Systems LLCWest Valley City, UT, United StatesComplaint file establishment, Manufacturer1July 31, 2023000api.fda.gov
Contra Healthcare Solutions LLCButler, PA, United StatesManufacturer, Specification developer1April 28, 2025000api.fda.gov
Karl Storz Endovision, Inc.Charlton, MA, United StatesContract manufacturer, Manufacturer1June 6, 2025000api.fda.gov
BiomericsSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Calyxo, Inc.Pleasanton, CA, United StatesManufacturer0000api.fda.gov
Calyxo, Inc.Pleasanton, CA, United StatesManufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Infinity Medical International LLCMiami, FL, United StatesManufacturer for export0000api.fda.gov
KARL STORZ Endovision, Inc.Franklin, MA, United StatesContract manufacturer0000api.fda.gov
Karl Storz Imaging, Inc.Goleta, CA, United StatesContract manufacturer0000api.fda.gov
Nissha Medical Technologies (Ohio), Inc.Norwalk, OH, United StatesContract manufacturer0000api.fda.gov
Richard Wolf Medical Instruments Corp.Vernon Hills, IL, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 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.