Edwards Lifesciences
🚨 Critical Risk
FEI: 3003242659 • Bajos De Haina, San Cristobal • DOMINICAN REPUBLIC
FEI
FEI Number
3003242659
📍
Location
Bajos De Haina, San Cristobal
🇩🇴
Country
DOMINICAN REPUBLIC🏢
Address
Parque Industrial Itabo Sa, , Bajos De Haina, San Cristobal, Dominican Republic
Critical Risk
FDA Import Risk Assessment
83.4
LowModerateHighCritical
This firm has an extensive history of FDA import refusals with severe violations.
Statistics
199
Total Refusals
3
Unique Violations
10/23/2025
Latest Refusal
10/13/2022
Earliest Refusal
Score Breakdown
Violation Severity
71.8×40%
Refusal Volume
85.2×30%
Recency
95.7×20%
Frequency
100.0×10%
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
50893×
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.
278085×
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
23739×
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/23/2025 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 237NO PMA | Division of Southeast Imports (DSEI) |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | Division of Southeast Imports (DSEI) | |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | Division of Southeast Imports (DSEI) | |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | Division of Southeast Imports (DSEI) | |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | Division of Southeast Imports (DSEI) | |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | Division of Southeast Imports (DSEI) | |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | Division of Southeast Imports (DSEI) | |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | Division of Southeast Imports (DSEI) | |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | Division of Southeast Imports (DSEI) | |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | Division of Southeast Imports (DSEI) | |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | Division of Southeast Imports (DSEI) | |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | Division of Southeast Imports (DSEI) | |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | Division of Southeast Imports (DSEI) | |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | Division of Southeast Imports (DSEI) | |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | Division of Southeast Imports (DSEI) | |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | Division of Southeast Imports (DSEI) | |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | Division of Southeast Imports (DSEI) | |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | Division of Southeast Imports (DSEI) | |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | Division of Southeast Imports (DSEI) | |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 237NO PMA | Division of Southeast Imports (DSEI) |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 237NO PMA | Division of Southeast Imports (DSEI) |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 237NO PMA | Division of Southeast Imports (DSEI) |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 237NO PMA | Division of Southeast Imports (DSEI) |
| 11/20/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 237NO PMA | Division of Southeast Imports (DSEI) |
| 9/3/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 237NO PMA | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 237NO PMA | Division of Southeast Imports (DSEI) |
| 5/15/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 237NO PMA | Division of Southeast Imports (DSEI) |
| 5/15/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 237NO PMA | Division of Southeast Imports (DSEI) |
| 5/15/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/26/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/26/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/26/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/24/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/24/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/24/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/24/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/5/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/5/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/5/2024 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | 237NO PMA | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Edwards Lifesciences's FDA import refusal history?
Edwards Lifesciences (FEI: 3003242659) has 199 FDA import refusal record(s) in our database, spanning from 10/13/2022 to 10/23/2025.
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's FEI number is 3003242659.
What types of violations has Edwards Lifesciences received?
Edwards Lifesciences 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 come from?
All FDA import refusal data for Edwards Lifesciences 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.