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GE MEDICAL SYSTEMS, ISRAEL LTD.

✅ Low Risk

FEI: 3002973981 • Haifa • ISRAEL

FEI

FEI Number

3002973981

📍

Location

Haifa

🇮🇱

Country

ISRAEL
🏢

Address

No. 1, Nativ Haaor Street, , Haifa, , Israel

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
11/3/2004
Latest Refusal
11/3/2004
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

3411×

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

DateProductViolationsDivision
11/3/2004
90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is GE MEDICAL SYSTEMS, ISRAEL LTD.'s FDA import refusal history?

GE MEDICAL SYSTEMS, ISRAEL LTD. (FEI: 3002973981) has 1 FDA import refusal record(s) in our database, spanning from 11/3/2004 to 11/3/2004.

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. GE MEDICAL SYSTEMS, ISRAEL LTD.'s FEI number is 3002973981.

What types of violations has GE MEDICAL SYSTEMS, ISRAEL LTD. received?

GE MEDICAL SYSTEMS, ISRAEL 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 GE MEDICAL SYSTEMS, ISRAEL LTD. come from?

All FDA import refusal data for GE MEDICAL SYSTEMS, ISRAEL 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.