# Edwards Lifesciences Services GmbH

- Location (FDA's records): Stevenage, GB
- FDA decisions: 3 (2007–2009): 3 510(k) clearances
- Product codes: KDI (2), FJK (1)
- Predicates its devices cite: 9 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Baxter Healthcare Corp: 3 (https://510kreport.com/company/baxter-healthcare)
- Gambro Renal Care Products: 1 (https://510kreport.com/company/gambro-renal-care-products)
- Gambro Healthcare: 1 (https://510kreport.com/company/gambro-healthcare)
- Cobe Renal Care, Inc.: 1 (https://510kreport.com/company/cobe-renal-care)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)
- Gambro, Inc.: 1 (https://510kreport.com/company/gambro)

## Its most-cited devices
- K070320: Edwards Aquarius Hemofiltration System, Model Abm 01 (2007), cited by 1

## Recent decisions
- K090682: Edwards Aquarius System, Model GE-F098-00 (Nov 19, 2009)
- K070320: Edwards Aquarius Hemofiltration System, Model Abm 01 (Jun 7, 2007)
- K063293: Edwards Aqualine Sterile Tubing Set; Edwards Aqualins Sterile Tubing Set;  Edwards Aquaspike and Aquasafe (Mar 23, 2007)

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