Data / Medical devices / Light Source, Fiberoptic, Routine / United States
FDA-registered makers of Light Source, Fiberoptic, Routine in the United States: 14 establishments
14 establishments in the United States are registered with the FDA to make Light Source, Fiberoptic, Routine (product code FCW). 8 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
- Light Source, Fiberoptic, Routine
- Product code
- FCW
- Country
- United States
Makers of Light Source, Fiberoptic, Routine in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Manufacturer | 2 | June 18, 2008 | 0 | 0 | 0 | api.fda.gov |
| Linvatec Corporation | Largo, FL, United States | Specification developer | 2 | June 18, 2008 | 0 | 0 | 0 | api.fda.gov |
| DePuy Mitek, Inc. | Raynham, MA, United States | Specification developer | 1 | December 19, 2012 | 0 | 0 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Manufacturer | 1 | October 17, 2001 | 0 | 0 | 0 | api.fda.gov |
| Innomed, Inc. | Savannah, GA, United States | Specification developer | 1 | January 3, 1994 | 0 | 0 | 0 | api.fda.gov |
| Novaprobe Inc. | Lansdale, PA, United States | Manufacturer | 1 | July 24, 2014 | 0 | 0 | 0 | api.fda.gov |
| Stryker Endoscopy | San Jose, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | December 19, 2008 | 0 | 1 | 0 | api.fda.gov |
| Sunoptic Technologies, LLC | Jacksonville, FL, United States | Contract manufacturer, Manufacturer | 1 | March 18, 2010 | 0 | 0 | 0 | api.fda.gov |
| Alliance Precision Plastics | Gates, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carestream Health, Inc. | Rochester, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fiberoptics Technology, Inc. | Pomfret, CT, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Endovision, Inc. | Charlton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| National Advanced Endoscopy Devices, Inc. | Canoga Park, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steripack Usa (limited) LLC | Lakeland, FL, 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.