Omnitron Intl., Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K901615PULMOCATH INTRABRONCHIAL CATHETERNovember 27, 1992
K923130IR-192 IMPLANT -- MODIFICATIONSeptember 21, 1992
K920431OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGEMay 29, 1992
K913908OMNITRON GYN APPLICATOR SYSTEMMarch 6, 1992
K915253IR-192 IMPLANT, MODIFICATIONFebruary 27, 1992
K911775OMNICATH IMPLANTED CATHETER AND DEPOTMay 8, 1991
K881665OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATORAugust 11, 1988