Data / Medical devices / Device, Communications, Images, Ophthalmic
Device, Communications, Images, Ophthalmic (NFG): 17 FDA-registered makers in 7 countries
17 establishments in 7 countries are registered with the FDA to make Device, Communications, Images, Ophthalmic (product code NFG, Class 1, 21 CFR 892.2020). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- NFG
- Device class
- 1
- Regulation
- 892.2020
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Germany | 5 |
| Japan | 2 |
| Netherlands | 1 |
| Taiwan | 1 |
| Canada | 1 |
| Vietnam | 1 |
Makers of Device, Communications, Images, Ophthalmic
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 |
|---|---|---|---|---|---|---|---|---|
| Carl Zeiss Meditec AG (jena) | JENA Thuringia, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CARL ZEISS MEDITEC AG (Munich) | Muenchen Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carl Zeiss Meditec AG (Jena) | Jena Thuringia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cassini Technologies B.V. | The Hague Zuid-Holland, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Joslin Diabetes Center | Boston, MA, United States | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medimaging Integrated Solution Inc. | Hsinchu Hsinchu(City), Taiwan | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nidek Co., Ltd. | Gamagori, Aichi, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nidek Co., Ltd. Hamacho Plant | Gamagori, Aichi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nidek Incorporated | The Colony, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Od-Os GMBH | Teltow Brandenburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Optina Diagnostics Inc. | Montreal Quebec, Canada | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Technology Group LLC | Pleasanton, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Retivue LLC | Charlottesville, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Inc. | Andover, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taishodo Vietnam Co., Ltd. | Dai An Industrial Zone Hai Duong, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WaveLight GmbH | Teltow Brandenburg, Germany | 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.