Augmenix, Inc.
Waltham, MA, US
Augmenix, Inc. appears in FDA device records in Waltham, MA. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 5
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 5 510(k) clearances for Augmenix, Inc. between 2013 and 2019. The busiest year on record is 2015, with 2. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2015 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K182971 | SpaceOAR Vue Hydrogel | OVB | Substantially Equivalent | |
| K181465 | SpaceOAR System | OVB | Substantially Equivalent | |
| K151998 | TraceIT Tissue Marker - 3mL | NEU | Substantially Equivalent | |
| DEN140030 | SpaceOAR System | OVB | Unknown | |
| K121964 | MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML | NEU | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain