Data / Medical devices / Japan / Harada
Harada: FDA-registered device maker in Osaka, Japan, 1 510(k) clearance
Harada is registered with the FDA (registration 3003183807) in Osaka, Japan. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 12, 1986. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003183807
- Address
- 2-10-14, Minamisemba, Chuo-Ku, Osaka, Japan, 542-0081
- Owner or operator
- Harada (10089961)
- Roles
- Specification developer
- First device listed
- January 26, 2024
- Registered through
- 2026
- Brand names listed
- EFER-DUMON BRONCHOSCOPE SYSTEM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 12, 1986 | K854414 | DUMON/HARRELL | EOQ | Substantially Equivalent | Bryan Corp. | accessdata.fda.gov |
Compare with other makers
Updated March 12, 1986. 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.