Medical Device Manufacturer · US , Waltham , MA

Augmenix, Inc. - FDA 510(k) Cleared Devices

5 submissions · 4 cleared · Since 2013
5
Total
4
Cleared
1
Denied

FDA 510(k) cleared devices by Augmenix, Inc. Radiology ✕

3 devices
1-3 of 3
Cleared Jul 19, 2019
SpaceOAR Vue Hydrogel
K182971 · OVB
Radiology · 266d
Cleared Jun 25, 2018
SpaceOAR System
K181465 · OVB
Radiology · 21d
Not Cleared Apr 01, 2015
SpaceOAR System
DEN140030 · OVB
Radiology · 182d
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