# Edwards Orthopaedics Div., Baxter Healthcare Corp.

- Location (FDA's records): Santa Ana, CA
- FDA decisions: 2 (1988–1988): 2 510(k) clearances
- Product codes: KGS (1), HRX (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (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 that cite its devices most
- Tuta Healthcare Pty Limited: 1 (https://510kreport.com/company/tuta-healthcare)

## Its most-cited devices
- K883300: Irrigation Set (1988), cited by 1

## Recent decisions
- K883300: Irrigation Set (Nov 1, 1988)
- K883299: Suture Retention Device (Aug 23, 1988)

Source page: https://510kreport.com/company/edwards-orthopaedics-div-baxter-healthcare