Augmenix, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K182971SpaceOAR Vue HydrogelJuly 19, 2019
K181465SpaceOAR SystemJune 25, 2018
K151998TraceIT Tissue Marker - 3mLAugust 19, 2015
DEN140030SpaceOAR SystemApril 1, 2015
K121964MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10MLJanuary 23, 2013