Data / Medical devices / United States / Nemoto North America, Inc.
Nemoto North America, Inc.: FDA-registered device maker in North Ridgeville, OH, United States, 1 510(k) clearance
Nemoto North America, Inc. is registered with the FDA (registration 3014498725) in North Ridgeville, OH, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 27, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014498725
- Address
- 37160 Sugar Ridge Rd, North Ridgeville, OH, United States, 44039
- Owner or operator
- Nemoto North America, Inc. (10057761)
- Roles
- Specification developer
- First device listed
- August 28, 2024
- Registered through
- 2026
- Brand names listed
- Disposable Syringe (Kit), Nemoto Disposable Syringe (Kit), TM0539003, TM0539010, TM0539AE, TM0539K, TM0539L, TM0539M and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | 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 |
|---|---|---|---|---|---|---|
| August 27, 2024 | K242212 | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) | DXT | Substantially Equivalent | Nemoto Kyorindo Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 27, 2024. 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.