Augmenix, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Augmenix, Inc. - FDA 510(k) Cleared Devices
Recent clearances: SpaceOAR Vue Hydrogel, SpaceOAR System
5
Total
4
Cleared
1
Denied
Augmenix, Inc. has 4 FDA 510(k) cleared medical devices. Based in Waltham, US.
Historical record: 4 cleared submissions from 2013 to 2019. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Augmenix, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Boston Scientific as regulatory consultant.
FDA 510(k) Regulatory Record - Augmenix, Inc.
5 devices
Cleared
Jul 19, 2019
SpaceOAR Vue Hydrogel
Radiology
266d
Cleared
Jun 25, 2018
SpaceOAR System
Radiology
21d
Cleared
Aug 19, 2015
TraceIT Tissue Marker - 3mL
General & Plastic Surgery
30d
Not Cleared
Apr 01, 2015
SpaceOAR System
Radiology
182d
Cleared
Jan 23, 2013
MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML
General & Plastic Surgery
202d