Data / Medical devices / Headlight, Fiberoptic Focusing
Headlight, Fiberoptic Focusing (FCT): 13 FDA-registered makers in 5 countries
13 establishments in 5 countries are registered with the FDA to make Headlight, Fiberoptic Focusing (product code FCT, Class 2, 21 CFR 886.4335). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on August 26, 1996, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FCT
- Device class
- 2
- Regulation
- 886.4335
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Germany | 3 |
| Argentina | 1 |
| United Arab Emirates | 1 |
| Latvia | 1 |
Makers of Headlight, Fiberoptic Focusing
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ecleris SRL | Villa Martelli Buenos Aires, Argentina | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eusa Global LLC | Medley, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fiberoptics Technology, Inc. | Pomfret, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heine Optotechnik GMBH & Co. KG. | GILCHING Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Illumination International, Inc | Chatsworth, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Perfect Ophthalmic Instruments FZE | Dubai Dubayy, United Arab Emirates | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qed, Inc. | Lexington, KY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RUMEX Baltics SIA | Riga, Latvia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RZ Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vitalcor, Inc. | Westmont, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 26, 1996. 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.