Cortex, Inc.
United StatesFDA applicant, unverified FDA FEI 3013627970
Cortex, Inc. is a medical device manufacturer, with 16 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 12 Nov 2026.
- Devices
- 16
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 14
- FDA 510(k) 2
- Device classes
- FDA Class II 16
- Identifiers
- FDA FEI 3013627970
- DUNS 119228234
At a glance
Market reach
- United States
- FDA FEI
Catalogue
Search and filter all 16 devicesCompany details
- FDA FEI number
- 3013627970
- DUNS number
- 119228234
- Address
- 5455 Great America Parkway Ste 301, Santa Clara, CA, 95054
Frequently asked questions
How many devices does Cortex, Inc. have in the registry?
The registry currently lists 16 devices for Cortex, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cortex, Inc.'s devices?
Among its 16 most recently registered devices, Cortex, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (14 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Cortex, Inc.'s devices fall under?
Among its 16 most recently registered devices, the classes recorded for Cortex, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cortex, Inc. in the registry?
The most recently registered devices listed for Cortex, Inc. include OptiMap Catheter - 60mm OPTI-CATH2-60, OptiMap Catheter - 50mm OPTI-CATH2-50, OptiMap™ System - NA FG0001-NA and OptiMap™ ECG Cables - NA FG0012-NA.