HAYEK MEDICAL DEVICES (NORTH AMERICA) LTD
⚠️ Moderate Risk
FEI: 3013059333 • Milton, Ontario • CANADA
FEI Number
3013059333
Location
Milton, Ontario
Country
CANADAAddress
8193 Esquesing Line, , Milton, Ontario, Canada
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 |
|---|---|---|---|
| 3/22/2024 | 73BYTVENTILATOR, EXTERNAL BODY, NEGATIVE PRESSURE, ADULT (CUIRASS) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/22/2024 | 73BYTVENTILATOR, EXTERNAL BODY, NEGATIVE PRESSURE, ADULT (CUIRASS) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/22/2024 | 73BYTVENTILATOR, EXTERNAL BODY, NEGATIVE PRESSURE, ADULT (CUIRASS) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/22/2024 | 73BYTVENTILATOR, EXTERNAL BODY, NEGATIVE PRESSURE, ADULT (CUIRASS) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/22/2024 | 73BYTVENTILATOR, EXTERNAL BODY, NEGATIVE PRESSURE, ADULT (CUIRASS) | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HAYEK MEDICAL DEVICES (NORTH AMERICA) LTD's FDA import refusal history?
HAYEK MEDICAL DEVICES (NORTH AMERICA) LTD (FEI: 3013059333) has 5 FDA import refusal record(s) in our database, spanning from 3/22/2024 to 3/22/2024.
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. HAYEK MEDICAL DEVICES (NORTH AMERICA) LTD's FEI number is 3013059333.
What types of violations has HAYEK MEDICAL DEVICES (NORTH AMERICA) LTD received?
HAYEK MEDICAL DEVICES (NORTH AMERICA) LTD 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 HAYEK MEDICAL DEVICES (NORTH AMERICA) LTD come from?
All FDA import refusal data for HAYEK MEDICAL DEVICES (NORTH AMERICA) LTD 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.