Data / Medical devices / Choledochoscope And Accessories, Flexible/Rigid / United States
FDA-registered makers of Choledochoscope And Accessories, Flexible/Rigid in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Choledochoscope And Accessories, Flexible/Rigid (product code FBN). 6 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Choledochoscope And Accessories, Flexible/Rigid
- Product code
- FBN
- Country
- United States
Makers of Choledochoscope And Accessories, Flexible/Rigid in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 2 | May 21, 2020 | 0 | 1 | 0 | api.fda.gov |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 2 | May 21, 2020 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 2 | May 21, 2020 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer | 1 | January 22, 2019 | 0 | 0 | 0 | api.fda.gov |
| Centerpoint Systems LLC | West Valley City, UT, United States | Complaint file establishment, Manufacturer | 1 | May 2, 2024 | 0 | 0 | 0 | api.fda.gov |
| Tangent Endoscopy, LLC | Camden, DE, United States | Specification developer | 1 | September 12, 2025 | 0 | 1 | 0 | api.fda.gov |
| Cordica Medical, Inc. | Sunrise, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Enercon Technologies | Gray, ME, 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 | |
| OTU Medical Inc | Union City, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf Medical Instruments Corp. | Vernon Hills, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.