Skip to content

Edwards Lifesciences Technology SARL

Country not established FDA establishment FEI 2648045

Devices
0
Registrations
FDA
FDA recalls
1

No devices from this company are in the catalogue yet.

Company details

FDA FEI number
2648045
Address
STATE ROAD 402, KM 1.4, Industrial Park, ANASCO, PR, 00610

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

  • 2006

    • 27 Nov 2006 Z-0338-2007 Unclassified (pre-2012) Terminated Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with different model information (831F75) on the edge label . The edge label states the model is 831F75 which incorrectly indicates that product does NOT contain an antimicrobial heparin coating. (The tray lid label correctly states the model is 831HF75, containing the heparin coating) Distribution: Worldwide Distribution ----USA and countries of Columbia and Venezuela. Submission number: K812563

This is an FDA establishment record without devices in deviCERTS.