Theragenics Corporation

FDA Regulatory Profile

Theragenics Corporation appears in FDA public data with 1 recall, 0 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0643-2019, Class II) was initiated on October 9, 2018.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0643-2019Class IITheragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stOctober 9, 2018