Gendex Corp
FDA Regulatory Profile
Gendex Corp appears in FDA public data with 1 recall, 14 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0009-2015, Class II) was initiated on August 12, 2014. Its most recent 510(k) clearance was granted on June 29, 1995.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 14
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0009-2015 | Class II | eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert | August 12, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K952598 | GX-PAN PANORAMIC DENTAL X-RAY SYSTEM | June 29, 1995 |
| K945682 | PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL | February 9, 1995 |
| K935046 | GX-770 X-RAY CONTROL, MODEL 46-404600G4 | February 18, 1994 |
| K925094 | VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS | September 29, 1993 |
| K931001 | ORALIX DC | September 14, 1993 |
| K932675 | GXP DENTAL X-RAY PROCESSOR | July 26, 1993 |
| K922165 | ATC725, ATC525, AND AP300 | July 27, 1992 |
| K920189 | GX-C CEPHALOMETER | April 28, 1992 |
| K894188 | GX-ELEVATOR | October 3, 1989 |
| K890083 | GX-2000 STATIONARY X-RAY GENERATOR | March 31, 1989 |
| K873982 | GX-MOBILE X-RAY UNIT | October 30, 1987 |
| K854499 | GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR | April 22, 1986 |
| K854459 | TBX MEDICAL X-RAY TABLE | February 12, 1986 |
| K842463 | GX CEPH | August 2, 1984 |