Isoray Medical, Inc.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesDecember 31, 2020
K180515GammaTileJuly 6, 2018
K111931GLIASITE RTSAugust 5, 2011
K092458PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLEAugust 28, 2009
K092136PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5August 7, 2009