Data / Medical devices / Endoscopic Cytology Brush / United States
FDA-registered makers of Endoscopic Cytology Brush in the United States: 15 establishments
15 establishments in the United States are registered with the FDA to make Endoscopic Cytology Brush (product code FDX). 12 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Endoscopic Cytology Brush
- Product code
- FDX
- Country
- United States
Makers of Endoscopic Cytology Brush in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 3 | June 26, 2019 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 3 | June 26, 2019 | 0 | 0 | 0 | api.fda.gov |
| Hobbs Medical, Inc. | Stafford Springs, CT, United States | Contract manufacturer, Manufacturer | 2 | August 28, 1989 | 0 | 3 | 0 | api.fda.gov |
| TeleMed Systems | Northborough, MA, United States | Specification developer | 2 | July 16, 1990 | 0 | 0 | 0 | api.fda.gov |
| United States Endoscopy Group, Inc. | Mentor, OH, United States | Manufacturer | 2 | July 30, 2015 | 0 | 0 | 0 | api.fda.gov |
| Wilson-Cook Medical Inc. | Winston Salem, NC, United States | Complaint file establishment, Manufacturer | 2 | November 14, 2019 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 1 | September 3, 1993 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer | 1 | September 3, 1993 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 1 | September 3, 1993 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Westborough, MA, United States | Specification developer | 1 | October 1, 1979 | 0 | 0 | 0 | api.fda.gov |
| Endo-Therapeutics, Inc. | Clearwater, FL, United States | Manufacturer | 1 | May 8, 1980 | 0 | 0 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | August 24, 1990 | 0 | 0 | 0 | api.fda.gov |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Annex Medical, Inc. | Minnetonka, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avanos Medical, Inc. | Alpharetta, GA, United States | Specification developer | 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.