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Tyco Healthcare

⚠️ Moderate Risk

FEI: 3003947594 • Kanata, ON • CANADA

FEI

FEI Number

3003947594

📍

Location

Kanata, ON

🇨🇦

Country

CANADA
🏢

Address

303 Terru Fox, , Kanata, ON, Canada

Moderate Risk

FDA Import Risk Assessment

37.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
2
Unique Violations
6/24/2004
Latest Refusal
6/24/2004
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1262×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

5082×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
6/24/2004
74DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
126FAILS STD
508NO 510(K)
Cincinnati District Office (CIN-DO)
6/24/2004
74DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
126FAILS STD
508NO 510(K)
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Tyco Healthcare's FDA import refusal history?

Tyco Healthcare (FEI: 3003947594) has 2 FDA import refusal record(s) in our database, spanning from 6/24/2004 to 6/24/2004.

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. Tyco Healthcare's FEI number is 3003947594.

What types of violations has Tyco Healthcare received?

Tyco Healthcare has been cited for 2 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 Tyco Healthcare come from?

All FDA import refusal data for Tyco Healthcare 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.