Data / Medical devices / Microscope, Specular / Japan
FDA-registered makers of Microscope, Specular in Japan: 6 establishments
6 establishments in Japan are registered with the FDA to make Microscope, Specular (product code NQE). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Microscope, Specular
- Product code
- NQE
- Country
- Japan
Makers of Microscope, Specular in Japan
| 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 |
| 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 Yamagata Co., LTD | Yamagata-KEN, Japan | Contract 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.