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Biosense Webster (israel), Ltd.

✅ Low Risk

FEI: 3008203003 • Yoqne'Am Illit • ISRAEL

FEI

FEI Number

3008203003

📍

Location

Yoqne'Am Illit

🇮🇱

Country

ISRAEL
🏢

Address

4, Hatnufah Street, , Yoqne'Am Illit, , Israel

Low Risk

FDA Import Risk Assessment

21.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
11/22/2010
Latest Refusal
11/22/2010
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

3413×

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
11/22/2010
74DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
341REGISTERED
Florida District Office (FLA-DO)
11/22/2010
74DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
341REGISTERED
Florida District Office (FLA-DO)
11/22/2010
74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Biosense Webster (israel), Ltd.'s FDA import refusal history?

Biosense Webster (israel), Ltd. (FEI: 3008203003) has 3 FDA import refusal record(s) in our database, spanning from 11/22/2010 to 11/22/2010.

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. Biosense Webster (israel), Ltd.'s FEI number is 3008203003.

What types of violations has Biosense Webster (israel), Ltd. received?

Biosense Webster (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 Biosense Webster (israel), Ltd. come from?

All FDA import refusal data for Biosense Webster (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.