Ge Medical Systems
⚠️ Moderate Risk
FEI: 3004774651 • Menomonie, WI • UNITED STATES
FEI Number
3004774651
Location
Menomonie, WI
Country
UNITED STATESAddress
W126 N7449 Flint Rdbldg#401 2nd Floor, , Menomonie, WI, United States
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
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.
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/6/2005 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Florida District Office (FLA-DO) | |
| 1/19/2005 | 74DPSELECTROCARDIOGRAPH | Florida District Office (FLA-DO) | |
| 12/20/2004 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | 508NO 510(K) | Florida District Office (FLA-DO) |
| 11/23/2004 | 74DXQCUFF, BLOOD-PRESSURE | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Ge Medical Systems's FDA import refusal history?
Ge Medical Systems (FEI: 3004774651) has 4 FDA import refusal record(s) in our database, spanning from 11/23/2004 to 4/6/2005.
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's FEI number is 3004774651.
What types of violations has Ge Medical Systems received?
Ge Medical Systems has been cited for 3 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 come from?
All FDA import refusal data for Ge Medical Systems 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.