Data / Medical devices / Illuminator, Fiberoptic, Surgical Field / United States
FDA-registered makers of Illuminator, Fiberoptic, Surgical Field in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Illuminator, Fiberoptic, Surgical Field (product code HBI). 7 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
- Illuminator, Fiberoptic, Surgical Field
- Product code
- HBI
- Country
- United States
Makers of Illuminator, Fiberoptic, Surgical Field in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | Saint Louis, MO, United States | Manufacturer | 2 | April 19, 1991 | 0 | 0 | 0 | api.fda.gov |
| Covidien | North Haven, CT, United States | Specification developer | 1 | September 26, 1988 | 0 | 0 | 0 | api.fda.gov |
| Gulf Fiberoptics, Inc. | Oldsmar, FL, United States | Manufacturer | 1 | September 6, 2002 | 0 | 0 | 0 | api.fda.gov |
| Katalyst Surgical, LLC | Chesterfield, MO, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | April 9, 2015 | 0 | 0 | 0 | api.fda.gov |
| Medical Illumination International, Inc | Chatsworth, CA, United States | Manufacturer | 1 | November 21, 2016 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | March 23, 1992 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | March 23, 1992 | 0 | 0 | 0 | api.fda.gov |
| Nico Corporation | Indianapolis, IN, United States | 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 | |
| Sunoptic Technologies, LLC | Jacksonville, FL, United States | Contract manufacturer, 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.