Data / Medical devices / Medical Device Data System / Japan
FDA-registered makers of Medical Device Data System in Japan: 9 establishments
9 establishments in Japan are registered with the FDA to make Medical Device Data System (product code OUG). 0 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
- Medical Device Data System
- Product code
- OUG
- Country
- Japan
Makers of Medical Device Data System in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Fukuda Denshi Co., Ltd. | Shiroi-shi Chiba, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fukuda Denshi Co., Ltd. | Bunkyo-ku Tokyo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HOYA Corporation PENTAX Lifecare Division | KURIHARA-SHI Miyagi, Japan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HOYA Corporation PENTAX Lifecare Division | Akishima-shi Tokyo, Japan | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden Corp. | SHINJUKU-KU Tokyo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden Tomioka Production Center | TOMIOKA-SHI Gunma, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center | Tokorozawa Saitama, Japan | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex Corporation Techno Park | KOBE Hyogo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SYSMEX CORPORATION i-SQUARE | Kakogawa Hyogo, Japan | 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.