Data / Medical devices / Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use / Japan
FDA-registered makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use in Japan: 8 establishments
8 establishments in Japan are registered with the FDA to make Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use (product code LXG). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- Product code
- LXG
- Country
- Japan
Makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| ARKRAY Factory, Inc. | Koka-shi Shiga, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arkray, Inc. | Kamigyo-ku Kyoto, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hitachi High-Tech Corp., Naka Division | Hitachinaka-shi Ibaraki, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hitachi High-Tech Corp., Omuta Center | Omuta-shi Fukuoka, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex Corporation Kakogawa Factory | Kakogawa Hyogo, Japan | Manufacturer | 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 | |
| Sysmex RA Co., LTD, Main Office | Shiojiri Nagano, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.