# Edwards Lifesciencess, LLC

- Location (FDA's records): Irvine, CA
- FDA decisions: 1 (2023–2023): 1 510(k) clearance
- Product codes: DYG (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 2 (0 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
- Edwards Lifesciences, LLC: 4 (https://510kreport.com/company/edwards-lifesciences)

## Firms that cite its devices most
- Edwards Lifesciences, LLC: 2 (https://510kreport.com/company/edwards-lifesciences)

## Its most-cited devices
- K231248: Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform (2023), cited by 2

## Recent decisions
- K231248: Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform (Sep 21, 2023)

Source page: https://510kreport.com/company/edwards-lifesciencess