Encore Medical Inc.
⚠️ Moderate Risk
FEI: 3003215458 • Saint Paul, MN • UNITED STATES
FEI Number
3003215458
Location
Saint Paul, MN
Country
UNITED STATESAddress
2975 Lone Oak Dr Ste 140, , Saint Paul, MN, 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
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 |
|---|---|---|---|
| 9/2/2025 | 74MLVDEVICE, TRANSCATHETER CARDIAC OCCLUSION | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Encore Medical Inc.'s FDA import refusal history?
Encore Medical Inc. (FEI: 3003215458) has 1 FDA import refusal record(s) in our database, spanning from 9/2/2025 to 9/2/2025.
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. Encore Medical Inc.'s FEI number is 3003215458.
What types of violations has Encore Medical Inc. received?
Encore Medical Inc. has been cited for 1 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 Encore Medical Inc. come from?
All FDA import refusal data for Encore Medical Inc. 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.