Data / Medical devices / System, Measurement, Blood-Pressure, Non-Invasive / Japan
FDA-registered makers of System, Measurement, Blood-Pressure, Non-Invasive in Japan: 7 establishments
7 establishments in Japan are registered with the FDA to make System, Measurement, Blood-Pressure, Non-Invasive (product code DXN). 5 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
- System, Measurement, Blood-Pressure, Non-Invasive
- Product code
- DXN
- Country
- Japan
Makers of System, Measurement, Blood-Pressure, Non-Invasive in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| A&D Company, Limited - Tech Center | Kitamoto-shi Saitama, Japan | Complaint file establishment, Specification developer | 15 | October 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Omron Healthcare Co., Ltd. | MUKO Kyoto, Japan | Specification developer | 11 | April 1, 2021 | 0 | 0 | 0 | api.fda.gov |
| A&D Manufacturing Company, Limited - Tsukuba Factory | Shimotsuma-shi Ibaraki, Japan | Contract manufacturer, Manufacturer | 3 | April 24, 2019 | 0 | 0 | 0 | api.fda.gov |
| Fukuda Denshi Co., Ltd. | Shiroi-shi Chiba, Japan | Manufacturer | 1 | December 21, 2011 | 0 | 0 | 0 | api.fda.gov |
| Fukuda Denshi Co., Ltd. | Bunkyo-ku Tokyo, Japan | Specification developer | 1 | December 21, 2011 | 0 | 0 | 0 | api.fda.gov |
| Nihon Seimitsu Sokki Co., Ltd. | SHIBUKAWA Gunma, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OMRON HEALTHCARE Co., Ltd. Matsusaka Factory | Matsusaka Mie, 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.