Augmenix, Inc.
Augmenix, Inc. appears in FDA public data with 0 recalls, 5 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on July 19, 2019.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K182971 | SpaceOAR Vue Hydrogel | July 19, 2019 |
| K181465 | SpaceOAR System | June 25, 2018 |
| K151998 | TraceIT Tissue Marker - 3mL | August 19, 2015 |
| DEN140030 | SpaceOAR System | April 1, 2015 |
| K121964 | MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML | January 23, 2013 |