Company ยท US
Gendex Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1995. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | 4 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 3 |
| EAG | Cephalometer | 2 |
| EGN | Scissors, Surgical Tissue, Dental | 1 |
| EGY | Processor, Radiographic-Film, Automatic, Dental | 1 |
| GEX | Powered Laser Surgical Instrument | 1 |
| IXJ | Grid, Radiographic | 1 |
| IZL | System, X-Ray, Mobile | 1 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 29, 1995 | K952598 | GX-PAN PANORAMIC DENTAL X-RAY SYSTEM Gendex Corp. | GEX |
| Feb 9, 1995 | K945682 | PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL Gendex Corp. | EGY |
| Feb 18, 1994 | K935046 | GX-770 X-RAY CONTROL, MODEL 46-404600G4 Gendex Corp. | EHD |
| Sep 29, 1993 | K925094 | VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS Gendex Corp. | EHD |
| Sep 14, 1993 | K931001 | ORALIX DC Gendex Corp. | EHD |
| Jul 26, 1993 | K932675 | GXP DENTAL X-RAY PROCESSOR Gendex Corp. | EGN |
| Jul 27, 1992 | K922165 | ATC725, ATC525, AND AP300 Gendex Corp. | IZO |
| Apr 28, 1992 | K920189 | GX-C CEPHALOMETER Gendex Corp. | EAG |
| Oct 3, 1989 | K894188 | GX-ELEVATOR Gendex Corp. | IZZ |
| Mar 31, 1989 | K890083 | GX-2000 STATIONARY X-RAY GENERATOR Gendex Corp. | IZO |
| Oct 30, 1987 | K873982 | GX-MOBILE X-RAY UNIT Gendex Corp. | IZL |
| Apr 22, 1986 | K854499 | GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR Gendex Corp. | IZO |
| Feb 12, 1986 | K854459 | TBX MEDICAL X-RAY TABLE Gendex Corp. | IXJ |
| Aug 2, 1984 | K842463 | GX CEPH Gendex Corp. | EAG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2014 | Gendex Corp eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 5 Terminated |
EHD | K992610 |