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Data / Medical devices / Hysteroscope (And Accessories) / United States

FDA-registered makers of Hysteroscope (And Accessories) in the United States: 31 establishments

31 establishments in the United States are registered with the FDA to make Hysteroscope (And Accessories) (product code HIH). 22 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.

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Device
Hysteroscope (And Accessories)
Product code
HIH
Country
United States

Makers of Hysteroscope (And Accessories) in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
CovidienNorth Haven, CT, United StatesRepackager or relabeler, Specification developer9August 29, 2018000api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesComplaint file establishment, Specification developer9August 29, 2019000api.fda.gov
Caldera Medical, Inc.Westlake Village, CA, United StatesManufacturer, Repackager or relabeler, Specification developer5November 30, 2023000api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer5May 15, 2019020api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer4August 22, 2002000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesComplaint file establishment, Manufacturer, Specification developer4July 18, 2025000api.fda.gov
American Medical EndoscopyDoral, FL, United StatesRepackager or relabeler, Specification developer3June 4, 2026000api.fda.gov
Axora Medical, Inc.Sunnyvale, CA, United StatesComplaint file establishment, Specification developer3August 18, 2026000api.fda.gov
Meditrina, Inc.San Jose, CA, United StatesManufacturer, Specification developer2October 1, 2019000api.fda.gov
Minerva Surgical, Inc.Santa Clara, CA, United StatesManufacturer2January 16, 2020000api.fda.gov
Acuvu Medical System IncLos Altos, CA, United StatesSpecification developer1May 15, 2026000api.fda.gov
Cogentix Medical, Inc.Orangeburg, NY, United StatesComplaint file establishment, Manufacturer1November 16, 2007000api.fda.gov
Cogentix Medical, Inc.Westborough, MA, United StatesManufacturer1November 16, 2007000api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesManufacturer1November 13, 2015000api.fda.gov
National Advanced Endoscopy Devices, Inc.Canoga Park, CA, United StatesManufacturer, Repackager or relabeler1January 7, 2015000api.fda.gov
OBP Medical CorporationLawrence, MA, United StatesSpecification developer1December 4, 2009000api.fda.gov
Polygon Medical, Inc.Manalapan, NJ, United StatesSpecification developer1January 4, 2019000api.fda.gov
Schoelly Usa Inc.Northborough, MA, United StatesManufacturer1March 9, 2015000api.fda.gov
Stryker Sustainability SolutionsTempe, AZ, United StatesReprocessor, Specification developer1September 25, 2020000api.fda.gov
Stryker Sustainability Solutions - ChandlerChandler, AZ, United StatesReprocessor1September 25, 2020000api.fda.gov
Stryker Sustainability Solutions LakelandLakeland, FL, United StatesReprocessor1September 25, 2020000api.fda.gov
Uroviu CorporationLos Altos, CA, United StatesSpecification developer1November 23, 2021000api.fda.gov
Apical InstrumentsRedwood City, CA, United StatesContract manufacturer0000api.fda.gov
Atc Technologies Inc.Wilmington, MA, United StatesContract manufacturer0000api.fda.gov
Conmed CorporationUtica, NY, United StatesContract manufacturer0000api.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
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
Richard Wolf Medical Instruments Corp.Vernon Hills, IL, United StatesContract manufacturer0010api.fda.gov
Robling Medical, LLCYoungsville, NC, United StatesContract manufacturer0000api.fda.gov
Viant AS&O Holdings, LLCLaconia, NH, United StatesContract manufacturer0000api.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.