# Augmenix, Inc.

- Location (FDA's records): Waltham, MA
- FDA decisions: 5 (2013–2019): 4 510(k) clearances and 1 De Novo grant
- Product codes: OVB (3), NEU (2)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 7 (3 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Advanced Uroscience, Inc.: 1 (https://510kreport.com/company/advanced-uroscience)
- Bioform, Inc.: 1 (https://510kreport.com/company/bioform)

## Firms that cite its devices most
- Boston Scientific Corp: 3 (https://510kreport.com/company/boston-scientific)
- Bioprotect, Ltd.: 1 (https://510kreport.com/company/bioprotect)

## Its most-cited devices
- DEN140030: SpaceOAR System (2015), cited by 3
- K182971: SpaceOAR Vue Hydrogel (2019), cited by 2
- K181465: SpaceOAR System (2018), cited by 2

## Recent decisions
- K182971: SpaceOAR Vue Hydrogel (Jul 19, 2019)
- K181465: SpaceOAR System (Jun 25, 2018)
- K151998: TraceIT Tissue Marker - 3mL (Aug 19, 2015)
- DEN140030: SpaceOAR System (Apr 1, 2015)
- K121964: Markit Tissue Marker-1ML Markit Tissue Marker-3ML Markit Tissue Marker-10ML (Jan 23, 2013)

Source page: https://510kreport.com/company/augmenix