Edwards Lifesciences LLC

Entity profile compiled from public source records

Public Record Profile Registrations: 6 510(k) filings: 0 Recalls: 2

Known Identifiers & Locations

FEI Numbers 1713910, 2015691, 3007063218, 3015179394, 3015287573, 3017298588
Owner Operator Numbers 9040666
Locations Covered Changi South East, SG; Draper, UT, US; Guadalupe Cartago, CR; IRVINE, CA, US; Limerick Munster, IE; Shannon Clare, IE

Registered Establishments (6)

Registration # Establishment Name Location Establishment Type(s) Action
2015691 EDWARDS LIFESCIENCES LLC IRVINE, CA, US Develop Specifications But Do Not Manufacture At This Facility View Details
3007063218 EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd Changi South East, SG Manufacture Medical Device View Details
3008500478 Edwards Lifesciences LLC Draper, UT, US Manufacture Medical Device View Details
3015179394 Edwards Lifesciences LTD Shannon Clare, IE Manufacture Medical Device View Details
3015287573 Edwards Lifesciences Guadalupe Cartago, CR Manufacture Medical Device View Details
3017298588 Edwards Lifesciences Ireland Limited Limerick Munster, IE Manufacture Medical Device View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (2)

Recall # Product Description Initiation Date Status Action
Z-0002-2010 Edwards Lifesciences Fogaty Occlusion Catheter Ref # 62080822F. The product is intended for use in Temporary Vessel Occlusion. Reason: Several complaints were the two parts of the tubular package became loose under the shrink wrap that holds the DFU on the packaging tube. 2009-06-22 Terminated View Details
Z-0013-2009 Edwards Lifesciences***Fogarty Fortis***Arterial Embolectomy Catheter Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system. Reason: Potential for tubing fracture near the tip of the catheter. 2008-06-23 Terminated View Details

Profile Disclaimer

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