Data / Medical devices / Image, Illumination, Fiberoptic, For Endoscope / United States
FDA-registered makers of Image, Illumination, Fiberoptic, For Endoscope in the United States: 14 establishments
14 establishments in the United States are registered with the FDA to make Image, Illumination, Fiberoptic, For Endoscope (product code FFS). 5 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
- Image, Illumination, Fiberoptic, For Endoscope
- Product code
- FFS
- Country
- United States
Makers of Image, Illumination, Fiberoptic, For Endoscope 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 | 1 | November 20, 2007 | 0 | 1 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 1 | November 20, 2007 | 0 | 0 | 0 | api.fda.gov |
| Microvision, Inc. | Seabrook, NH, United States | Manufacturer | 1 | September 14, 1998 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer | 1 | January 20, 2000 | 0 | 1 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Andover, MA, United States | Specification developer | 1 | January 20, 2000 | 0 | 0 | 0 | api.fda.gov |
| Cogentix Medical, Inc. | Orangeburg, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cogentix Medical, Inc. | Westborough, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Command Medical Products, LLC. | Ormond Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gulf Fiberoptics, Inc. | Oldsmar, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | 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 | |
| Katalyst Surgical, LLC | Chesterfield, MO, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Endoscopy | San Jose, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunoptic Technologies, LLC | Jacksonville, FL, United States | Contract manufacturer, 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.