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

FDA-registered makers of Cystoscope And Accessories, Flexible/Rigid in the United States: 28 establishments

28 establishments in the United States are registered with the FDA to make Cystoscope And Accessories, Flexible/Rigid (product code FAJ). 16 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.

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Device
Cystoscope And Accessories, Flexible/Rigid
Product code
FAJ
Country
United States

Makers of Cystoscope 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 relabeler8August 13, 2025000api.fda.gov
Uroviu CorporationLos Altos, CA, United StatesComplaint file establishment, Specification developer6October 23, 2025000api.fda.gov
American Medical EndoscopyDoral, FL, United StatesRepackager or relabeler, Specification developer4March 27, 2026000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Specification developer3November 19, 2001000api.fda.gov
Caldera Medical, Inc.Westlake Village, CA, United StatesManufacturer2June 30, 2021000api.fda.gov
Cogentix Medical, Inc.Orangeburg, NY, United StatesComplaint file establishment, Manufacturer, Specification developer2April 7, 2026000api.fda.gov
Medivators IncConroe, TX, United StatesManufacturer2March 1, 2023000api.fda.gov
OTU Medical IncUnion City, CA, United StatesManufacturer, Specification developer2September 29, 2023000api.fda.gov
Cogentix Medical, Inc.Westborough, MA, United StatesManufacturer1December 18, 2007000api.fda.gov
Customed, Inc.Fajardo, PR, United StatesManufacturer1September 20, 1990020api.fda.gov
Emmy Medical, LLCWeston, MA, United StatesSpecification developer1December 19, 2014000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer1November 19, 2001000api.fda.gov
National Advanced Endoscopy Devices, Inc.Canoga Park, CA, United StatesManufacturer, Repackager or relabeler1December 15, 1999000api.fda.gov
Prosurg, IncSan Jose, CA, United StatesManufacturer1September 11, 2012000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1December 18, 2007000api.fda.gov
Zenflow, Inc.South San Francisco, CA, United StatesComplaint file establishment, Manufacturer1September 23, 2025000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesSpecification developer0000api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer0000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer0000api.fda.gov
Command Medical Products, LLC.Ormond Beach, FL, United StatesContract manufacturer0000api.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.Charlton, MA, 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
Robling Medical, LLCYoungsville, NC, United StatesContract manufacturer0000api.fda.gov
Schoelly Usa Inc.Northborough, MA, United StatesManufacturer0000api.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.