Data / Medical devices / Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) / Japan
FDA-registered makers of Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) in Japan: 5 establishments
5 establishments in Japan are registered with the FDA to make Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) (product code DRT). 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
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Product code
- DRT
- Country
- Japan
Makers of Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Nihon Kohden Corp. | SHINJUKU-KU Tokyo, Japan | Specification developer | 1 | February 3, 2005 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Tomioka Production Center | TOMIOKA-SHI Gunma, Japan | Manufacturer | 1 | February 3, 2005 | 0 | 0 | 0 | api.fda.gov |
| 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 | |
| Nihon Vinyl Cord Corporation - Kodama Second Factory | Honjo-shi Saitama, Japan | Contract 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.