Contract manufacturerPro-Dex Inc (Tustin, CA)CaliforniaGeneral and plastic surgeryNeurologyOrthopedicClass IClass II
Pro-Dex Inc
Contract manufacturer · Tustin, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3024788684 (openFDA record; or search FDA's registration database)
- FEI number
- 3024788684
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Specification developer; Manufacturer; Contract manufacturer
- Owner or operator
- PRO-DEX, INC. (FDA owner/operator no. 2081135)
- Registered address
- 14401 Franklin Ave, Tustin, CA 92780
- Contract listings
- 6 device listings, 6 product codes, first listed Oct 23, 1992
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| FSM | Tray, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Mar 23, 2021 |
| GEY | Motor, Surgical Instrument, Ac-Powered | Class I | General and plastic surgery | Contract manufacturing | Oct 23, 1992 |
| GXL | Screwdriver, Skullplate | Class I | Neurology | Contract manufacturing | Mar 28, 2013 |
| HRX | Arthroscope | Class II | Orthopedic | Contract manufacturing | Mar 28, 2013 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract manufacturing | Feb 13, 2020 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Mar 7, 2015 |