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Radiadyne, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K162954OARtrac System with Patient Specific Reusable Universal PSD SensorsJune 1, 2017
K150719OARtrac System with Skin SensorsJune 16, 2015
K141154OARTRAC SYSTEMJuly 22, 2014
DEN130036PROSTATE IMMOBILIZER RECTAL BALLOONJanuary 28, 2014
K092534ALATUS VAGINAL BALLOON PACKING SYSTEMDecember 7, 2009