Data / Medical devices / United States / Pro-Dex Inc
Pro-Dex Inc: FDA-registered device maker in Tustin, CA, United States, 1 510(k) clearance
Pro-Dex Inc is registered with the FDA (registration 3024788684) in Tustin, CA, United States. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 2, 2002. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024788684
- Address
- 14401 Franklin Ave, Tustin, CA, United States, 92780
- Owner or operator
- PRO-DEX, INC. (2081135)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- October 23, 1992
- Registered through
- 2026
- Brand names listed
- Atlas Pro Driver (APD-1000-1), Atlas Pro Driver Battery Single Use Battery Case (APD-BP-010S-1), Atlas Pro Driver Hex Collet (APD-CA-001-1), Dynatip P/N 3293 Tip, Cover / Protector, PDCMF Driver (PDCMF-1000-X), PDCMF Power Driver (PDCMF-1000-X), Pro-Dex Surgical Driver (PDSD-5000-X), Pro-Dex Surgical Driver, Single Pouch Battery Pack (PDBP-001-X; PDBP-010-X; PDBD-040-X) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Contract manufacturer | accessdata.fda.gov |
| Bit, Surgical | GFG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Motor, Surgical Instrument, Ac-Powered | GEY | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Contract manufacturer | accessdata.fda.gov |
| Scaler, Periodontic | EMN | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screwdriver, Skullplate | GXL | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| August 2, 2002 | K012105 | POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM | KCT | Substantially Equivalent | Symmetry Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Scaler, Periodontic
- All makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- All makers of Arthroscope
- All makers of Screwdriver, Skullplate
- All makers of Tray, Surgical, Instrument
Updated August 2, 2002. 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.