Gendex Corp.
Medical device manufacturer in Hatfield, PA.
14510(k) clearances
0PMA approvals
1recalls
Device types
- IZO Generator, High-Voltage, X-Ray, Diagnostic 3
- EHD Unit, X-Ray, Extraoral With Timer 3
- EAG Cephalometer 2
- IXJ Grid, Radiographic 1
- IZL System, X-Ray, Mobile 1
- IZZ Table, Radiographic, Non-Tilting, Powered 1
- EGN Scissors, Surgical Tissue, Dental 1
- EGY Processor, Radiographic-Film, Automatic… 1
- GEX Powered Laser Surgical Instrument 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K952598 | Gx-Pan Panoramic Dental X-Ray SystemGEX · Traditional | 06/29/1995SE |
| K945682 | Processor, Radiographic-Film, Automatic, DentalEGY · Traditional | 02/09/1995SE |
| K935046 | GX-770 X-Ray Control, Model 46-404600G4EHD · Traditional | 02/18/1994SE |
| K925094 | Visualix Radiographic Image Detecting and ProcessEHD · Traditional | 09/29/1993SE |
| K931001 | Oralix DCEHD · Traditional | 09/14/1993SE |
| K932675 | GXP Dental X-Ray ProcessorEGN · Traditional | 07/26/1993SE |
| K922165 | ATC725, ATC525, and AP300IZO · Traditional | 07/27/1992SE |
| K920189 | Gx-C CephalometerEAG · Traditional | 04/28/1992SE |
| K894188 | Gx-ElevatorIZZ · Traditional | 10/03/1989SE |
| K890083 | GX-2000 Stationary X-Ray GeneratorIZO · Traditional | 03/31/1989SE |
| K873982 | Gx-Mobile X-Ray UnitIZL · Traditional | 10/30/1987SE |
| K854499 | Gendex Prince 30 Medical X-Ray GeneratorIZO · Traditional | 04/22/1986SE |
| K854459 | TBX Medical X-Ray TableIXJ · Traditional | 02/12/1986SE |
| K842463 | GX CephEAG · Traditional | 08/02/1984SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0009-2015 Class II | eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch…Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke… | 08/12/2014Terminated |