Data / Medical devices / Taiwan / Onyx Healthcare Inc.
Onyx Healthcare Inc.: FDA-registered device maker in New Taipei City, Taiwan, 1 510(k) clearance
Onyx Healthcare Inc. is registered with the FDA (registration 3009879967) in New Taipei City, Taiwan. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 30, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009879967
- Address
- 4F., No. 135, Ln. 235, Baoqiao Rd., Xindian Dist., New Taipei City, Taiwan, 231
- Owner or operator
- ONYX Healthcare Inc. (10044484)
- Roles
- Manufacturer
- First device listed
- June 18, 2013
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | 2 | Manufacturer | accessdata.fda.gov |
| System, Communication, Powered | ILQ | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| November 30, 2012 | K122326 | SMARTTOOLS KNEE SYSTEM | OLO | Substantially Equivalent | Zimmer | accessdata.fda.gov |
Compare with other makers
Updated November 30, 2012. 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.