Not currently registered with FDA under this name
Gendex Corp.
Des Plaines, IL, United States. Named as applicant on 6 dental 510(k) clearances between 1984 and 1994. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 61984–1994
- Markets registered in
- 21 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 2 markets
Where regulators' registries name Gendex Corp. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Gendex Corp. | 6 clearances | 1984–1994 | Below |
| Taiwan | TFDA | Manufacturer | GENDEX CORPORATION | 1 | 1989–1989 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Gendex Corp. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 18 Feb 1994 | K935046 | GX-770 X-RAY CONTROL, MODEL 46-404600G4 | EHD Extraoral with Timer X-Ray Unit |
| 29 Sep 1993 | K925094 | VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS | EHD Extraoral with Timer X-Ray Unit |
| 14 Sep 1993 | K931001 | ORALIX DC | EHD Extraoral with Timer X-Ray Unit |
| 26 Jul 1993 | K932675 | GXP DENTAL X-RAY PROCESSOR | EGN Dental Surgical Tissue Scissors |
| 28 Apr 1992 | K920189 | GX-C CEPHALOMETER | EAG Cephalometer |
| 2 Aug 1984 | K842463 | GX CEPH | EAG Cephalometer |
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.