Company ยท US
Augmenix, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2019. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 19, 2019 | K182971 | SpaceOAR Vue Hydrogel Augmenix, Inc. | OVB |
| Jun 25, 2018 | K181465 | SpaceOAR System Augmenix, Inc. | OVB |
| Aug 19, 2015 | K151998 | TraceIT Tissue Marker - 3mL Augmenix, Inc. | NEU |
| Apr 1, 2015 | DEN140030 | SpaceOAR System Augmenix, Inc. | OVB |
| Jan 23, 2013 | K121964 | MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML Augmenix, Inc. | NEU |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||