Data / Medical devices / Refractometer, Ophthalmic / Japan
FDA-registered makers of Refractometer, Ophthalmic in Japan: 11 establishments
11 establishments in Japan are registered with the FDA to make Refractometer, Ophthalmic (product code HKO). 0 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Refractometer, Ophthalmic
- Product code
- HKO
- Country
- Japan
Makers of Refractometer, Ophthalmic in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Atago Co., Ltd. | Minato-ku Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Canon Components, Inc. | KODAMA-GUN Saitama, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Canon Inc. | Kawasaki Kanagawa, Japan | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Canon.Inc | OHTA-KU Tokyo, Japan | Specification developer | 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 | |
| Rexxam.co., Ltd. | Takamatsu Kagawa, Japan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Right MFG. Co., Ltd. | Itabashi-Ku Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tomey Corporation | NAGOYA Aichi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Topcon Corp. | Tokyo, Japan | Specification developer | 0 | 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.