Medical Device Depot Inc
✅ Low Risk
FEI: 3008346242 • Ellicott City, MD • UNITED STATES
FEI Number
3008346242
Location
Ellicott City, MD
Country
UNITED STATESAddress
3230 Bethany Ln Ste 8, , Ellicott City, MD, United States
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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 |
|---|---|---|---|
| 1/7/2012 | 73DQAOXIMETER | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Medical Device Depot Inc's FDA import refusal history?
Medical Device Depot Inc (FEI: 3008346242) has 1 FDA import refusal record(s) in our database, spanning from 1/7/2012 to 1/7/2012.
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. Medical Device Depot Inc's FEI number is 3008346242.
What types of violations has Medical Device Depot Inc received?
Medical Device Depot 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 Medical Device Depot Inc come from?
All FDA import refusal data for Medical Device Depot 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.