Data / Medical devices / Microscope, Specular
Microscope, Specular (NQE): 8 FDA-registered makers in 2 countries
8 establishments in 2 countries are registered with the FDA to make Microscope, Specular (product code NQE, Class 2, 21 CFR 886.1850). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on March 26, 2020, and lists 2 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- NQE
- Device class
- 2
- Regulation
- 886.1850
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| Japan | 6 |
| United States | 2 |
Makers of Microscope, Specular
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 |
|---|---|---|---|---|---|---|---|---|
| Nidek Co., Ltd. | Gamagori, Aichi, Japan | Specification developer | 3 | March 14, 2018 | 0 | 0 | 0 | api.fda.gov |
| Nidek Co., Ltd. Hamacho Plant | Gamagori, Aichi, Japan | Manufacturer | 3 | March 14, 2018 | 0 | 0 | 0 | api.fda.gov |
| Nidek Incorporated | The Colony, TX, United States | Manufacturer | 3 | March 14, 2018 | 0 | 2 | 0 | api.fda.gov |
| Konan Medical, Inc. | NISHINOMIYA Hyogo, Japan | Manufacturer | 2 | March 26, 2020 | 0 | 0 | 0 | api.fda.gov |
| Tomey Corporation | NAGOYA Aichi, Japan | Manufacturer | 1 | January 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Topcon Corp. | Tokyo, Japan | Specification developer | 1 | May 29, 2015 | 0 | 0 | 0 | api.fda.gov |
| Topcon Healthcare, Inc. | Oakland, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Topcon Yamagata Co., LTD | Yamagata-KEN, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 26, 2020. 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.