Data / Medical devices / Device, Storage, Images, Ophthalmic
Device, Storage, Images, Ophthalmic (NFF): 10 FDA-registered makers in 6 countries
10 establishments in 6 countries are registered with the FDA to make Device, Storage, Images, Ophthalmic (product code NFF, Class 1, 21 CFR 892.2010). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on June 21, 2002, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NFF
- Device class
- 1
- Regulation
- 892.2010
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| Germany | 4 |
| Japan | 2 |
| Switzerland | 1 |
| United States | 1 |
| Vietnam | 1 |
| Taiwan | 1 |
Makers of Device, Storage, 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 (Jena) | Jena Thuringia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haag-Streit AG | KOENIZ Bern, Switzerland | 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 | |
| Taishodo Vietnam Co., Ltd. | Dai An Industrial Zone Hai Duong, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taiwan Main Orthopaedic Biotechnology Co., Ltd | Taichung City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WaveLight GmbH | Teltow Brandenburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 21, 2002. 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.