Data / Medical devices / Colonoscope And Accessories, Flexible/Rigid / United States
FDA-registered makers of Colonoscope And Accessories, Flexible/Rigid in the United States: 14 establishments
14 establishments in the United States are registered with the FDA to make Colonoscope And Accessories, Flexible/Rigid (product code FDF). 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
- Colonoscope And Accessories, Flexible/Rigid
- Product code
- FDF
- Country
- United States
Makers of Colonoscope And Accessories, Flexible/Rigid in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Lumendi, LLC | Westport, CT, United States | Complaint file establishment, Specification developer | 4 | February 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| United States Endoscopy Group, Inc. | Mentor, OH, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | January 6, 2017 | 0 | 0 | 0 | api.fda.gov |
| Actuated Medical, Inc. | Bellefonte, PA, United States | Manufacturer | 1 | October 4, 2024 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 1 | September 30, 2014 | 0 | 0 | 0 | api.fda.gov |
| Neptune Medical, Inc | Burlingame, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 1 | September 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| Sheathing Technologies, Inc. | Morgan Hill, CA, United States | Manufacturer, Repackager or relabeler | 1 | August 3, 2010 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J Sterling Industries LLC | Kalamazoo, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Endovision, Inc. | Charlton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medivators Inc | Conroe, TX, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, INC | Stoughton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, Inc | W Bridgewater, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spirus Medical, LLC | W Bridgewater, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| rms Surgical | Anoka, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.