Data / Medical devices / Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) / Japan
FDA-registered makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) in Japan: 8 establishments
8 establishments in Japan are registered with the FDA to make Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (product code MHX). 5 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Product code
- MHX
- Country
- Japan
Makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Fukuda Denshi Co., Ltd. | Bunkyo-ku Tokyo, Japan | Specification developer | 8 | March 16, 2015 | 0 | 1 | 0 | api.fda.gov |
| Fukuda Denshi Co., Ltd. | Shiroi-shi Chiba, Japan | Manufacturer | 7 | March 16, 2015 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Corp. | SHINJUKU-KU Tokyo, Japan | Specification developer | 7 | July 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Tomioka Production Center | TOMIOKA-SHI Gunma, Japan | Manufacturer | 7 | July 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center | Tokorozawa Saitama, Japan | Complaint file establishment, Specification developer | 7 | July 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center | Fukaya-Shi Saitama, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Vinyl Cord Corporation - Kodama Second Factory | Honjo-shi Saitama, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Vinyl Cord Corporation - Shimo-ongata Factory | Hachioji-shi Tokyo, Japan | Contract 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.