# Bio2 Medical, Inc.

- Location (FDA's records): Golden, CO
- FDA decisions: 1 (2016–2016): 1 510(k) clearance
- Product codes: PNS (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- William Cook Europe Aps: 1 (https://510kreport.com/company/william-cook-europe)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Edwards Lifesciences, LLC: 1 (https://510kreport.com/company/edwards-lifesciences)
- Arrow Intl., Inc.: 1 (https://510kreport.com/company/arrow-intl)

## Recent decisions
- K160747: Angel Catheter (Jul 28, 2016)

Source page: https://510kreport.com/company/bio2-medical