Edwards Lifesciences, LLC
⚠️ Moderate Risk
FEI: 2015691 • Irvine, CA • UNITED STATES
FEI Number
2015691
Location
Irvine, CA
Country
UNITED STATESAddress
1 Edwards Way, , Irvine, CA, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/7/2020 | 74DXCCLAMP, VASCULAR | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 9/25/2020 | 74DXCCLAMP, VASCULAR | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 9/22/2020 | 74DXCCLAMP, VASCULAR | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 8/13/2020 | 74DXCCLAMP, VASCULAR | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 8/11/2020 | 74DXCCLAMP, VASCULAR | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 5/17/2005 | 74NPGCATHETER, INFUSION, SYRINGE | Southwest Import District Office (SWI-DO) | |
| 5/17/2005 | 74NPGCATHETER, INFUSION, SYRINGE | Southwest Import District Office (SWI-DO) | |
| 11/18/2002 | 74DXECATHETER, EMBOLECTOMY | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Edwards Lifesciences, LLC's FDA import refusal history?
Edwards Lifesciences, LLC (FEI: 2015691) has 8 FDA import refusal record(s) in our database, spanning from 11/18/2002 to 10/7/2020.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Edwards Lifesciences, LLC's FEI number is 2015691.
What types of violations has Edwards Lifesciences, LLC received?
Edwards Lifesciences, LLC has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Edwards Lifesciences, LLC come from?
All FDA import refusal data for Edwards Lifesciences, LLC is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.