# American Edwards Laboratories

- Location (FDA's records): Santa Ana, CA
- FDA decisions: 89 (1980–1987): 89 510(k) clearances
- Product codes: HRX (7), FRN (6), LIT (6), DQO (6), DYG (6), EZN (5), DXG (4), DQY (3), LJE (3), DSH (3), DWP (3), KOD (3)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 19 (0 its own)
- Recalls linked to its devices: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Edwards Lifesciences, LLC: 9 (https://510kreport.com/company/edwards-lifesciences)
- Cardiomedical GmbH: 2 (https://510kreport.com/company/cardiomedical)
- Innovision A/S: 2 (https://510kreport.com/company/innovision-a-s)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Lidco, Ltd.: 1 (https://510kreport.com/company/lidco)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)
- Heartport, Inc.: 1 (https://510kreport.com/company/heartport)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)

## Its most-cited devices
- K831949: Prosthetic Rings #4400 Mitral & 4500 (1983), cited by 2
- K832554: Fogarty 6MM Softjaw Clip (1983), cited by 2
- K810124: Swan-Ganz Vip Thermodilution Catheter (1981), cited by 2
- K810352: Swan-Ganz Flow-Directed Thermodilution (1981), cited by 2
- K810162: Fogarty Softjaw 6MM Spring Clip, #614-06 (1981), cited by 1
- K844090: Percutaneous Nephrostomy Trocar Sys (1984), cited by 1

## Recent decisions
- K873485: Edslab (R) Occlusion Balloon Catheter (Dec 3, 1987)
- K872596: Trantec Disposable Pressure Trans.53-600/F/F30 (Sep 30, 1987)
- K872529: Thermodilution Cardiac Output Computer, Mod. Com-2 (Sep 15, 1987)
- K870444: Homepro II Volumetric Infusion Pump (Apr 17, 1987)
- K864997: Medtrac VP Volumetric Infusion Pump (Feb 27, 1987)
- K864330: Shear Force Gauge (Jan 6, 1987)
- K862724: Vein Valve Cutter (Jan 2, 1987)
- K864155: Modification of Carpentier-Edwards Bioprosthesis (Nov 20, 1986)

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