Gendex Corp

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0009-2015Class IIeXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpertAugust 12, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K952598GX-PAN PANORAMIC DENTAL X-RAY SYSTEMJune 29, 1995
K945682PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTALFebruary 9, 1995
K935046GX-770 X-RAY CONTROL, MODEL 46-404600G4February 18, 1994
K925094VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESSSeptember 29, 1993
K931001ORALIX DCSeptember 14, 1993
K932675GXP DENTAL X-RAY PROCESSORJuly 26, 1993
K922165ATC725, ATC525, AND AP300July 27, 1992
K920189GX-C CEPHALOMETERApril 28, 1992
K894188GX-ELEVATOROctober 3, 1989
K890083GX-2000 STATIONARY X-RAY GENERATORMarch 31, 1989
K873982GX-MOBILE X-RAY UNITOctober 30, 1987
K854499GENDEX PRINCE 30 MEDICAL X-RAY GENERATORApril 22, 1986
K854459TBX MEDICAL X-RAY TABLEFebruary 12, 1986
K842463GX CEPHAugust 2, 1984