OHK MEDICAL DEVICES LTD
✅ Low Risk
FEI: 3003889520 • Haifa, HEFA • ISRAEL
FEI Number
3003889520
Location
Haifa, HEFA
Country
ISRAELAddress
16, Palyam St, , Haifa, HEFA, Israel
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 |
|---|---|---|---|
| 10/25/2013 | 79GAXTOURNIQUET, NONPNEUMATIC | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is OHK MEDICAL DEVICES LTD's FDA import refusal history?
OHK MEDICAL DEVICES LTD (FEI: 3003889520) has 1 FDA import refusal record(s) in our database, spanning from 10/25/2013 to 10/25/2013.
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. OHK MEDICAL DEVICES LTD's FEI number is 3003889520.
What types of violations has OHK MEDICAL DEVICES LTD received?
OHK MEDICAL DEVICES 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 OHK MEDICAL DEVICES LTD come from?
All FDA import refusal data for OHK MEDICAL DEVICES 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.