Data / Medical devices / Electrode, Ion Specific, Potassium / Japan
FDA-registered makers of Electrode, Ion Specific, Potassium in Japan: 8 establishments
8 establishments in Japan are registered with the FDA to make Electrode, Ion Specific, Potassium (product code CEM). 2 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
- Electrode, Ion Specific, Potassium
- Product code
- CEM
- Country
- Japan
Makers of Electrode, Ion Specific, Potassium in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Beckman Coulter K. K. | Sunto-Gun Shizuoka, Japan | Specification developer | 1 | December 23, 2011 | 0 | 0 | 0 | api.fda.gov |
| Furuno Electric Co., Ltd. | NISHINOMIYA-CITY Hyogo, Japan | Manufacturer | 1 | March 31, 2006 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter Mishima K.K. | SUNTO-GUN Shizuoka, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biolis Medical Corp. | Hino Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Canon Inc. | OTAWARA-SHI Tochigi, Japan | Contract manufacturer | 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 | |
| Horiba Ltd. | Kyoto, Japan | Contract manufacturer, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jeol Ltd. | Musashimurayama Tokyo, 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.