Data / Medical devices / United States / Onyx Healthcare Usa, Inc.

Onyx Healthcare Usa, Inc.: FDA-registered device maker in Orange, CA, United States, 1 510(k) clearance

Name: Onyx Healthcare Usa, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Onyx Healthcare Usa, Inc. is registered with the FDA (registration 3010209365) in Orange, CA, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 16, 2012. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3010209365
Address: 324 W Blueridge Ave, Orange, CA, United States, 92865
Owner or operator: ONYX Healthcare USA, Inc. (10043939)
Roles: Manufacturer
First device listed: April 9, 2013
Registered through: 2026
Brand names listed: STIMULATOR, NERVEStimulator, electrical, evoked responseNeurological stereotaxic InstrumentElectromyograph, diagnostic, System, communication, powered

Devices it lists

Device	Product code	Class	Role	Source
Electromyograph, Diagnostic	IKN	2	Manufacturer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Evoked Response	GWF	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve	ETN	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
March 16, 2012	K112718	NUVASIVE NVM5 SYSTEM	ETN	Substantially Equivalent	Nuvasive, Inc.	accessdata.fda.gov

Compare with other makers

Updated March 16, 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.