Data / Medical devices / Camera, Ophthalmic, Ac-Powered / Japan
FDA-registered makers of Camera, Ophthalmic, Ac-Powered in Japan: 9 establishments
9 establishments in Japan are registered with the FDA to make Camera, Ophthalmic, Ac-Powered (product code HKI). 8 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
- Camera, Ophthalmic, Ac-Powered
- Product code
- HKI
- Country
- Japan
Makers of Camera, Ophthalmic, Ac-Powered in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Topcon Corp. | Tokyo, Japan | Specification developer | 8 | August 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| Kowa Co. Ltd. Chofu | Chofu Tokyo, Japan | Manufacturer | 7 | September 10, 2019 | 0 | 0 | 0 | api.fda.gov |
| Canon Components, Inc. | KODAMA-GUN Saitama, Japan | Manufacturer | 5 | May 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| Canon Inc. | Kawasaki Kanagawa, Japan | Specification developer | 5 | May 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| Canon.Inc | OHTA-KU Tokyo, Japan | Specification developer | 5 | May 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| Nidek Co., Ltd. | Gamagori, Aichi, Japan | Specification developer | 4 | April 1, 2019 | 0 | 0 | 0 | api.fda.gov |
| Nidek Co., Ltd. Hamacho Plant | Gamagori, Aichi, Japan | Manufacturer | 4 | April 1, 2019 | 0 | 0 | 0 | api.fda.gov |
| Softcare Co., Ltd. | Fukutsu Fukuoka, Japan | Manufacturer | 1 | May 12, 2016 | 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.