Ge Medical

⚠️ Moderate Risk

FEI: 3003225744 • Freiburg im Breisgau, Baden-Wurttemberg • GERMANY

FEI

FEI Number

3003225744

📍

Location

Freiburg im Breisgau, Baden-Wurttemberg

🇩🇪

Country

GERMANY

🏢

Address

Munzinger Str. 3, , Freiburg im Breisgau, Baden-Wurttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

41.0

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

1/13/2006

Latest Refusal

10/8/2001

Earliest Refusal

Score Breakdown

Violation Severity

51.9×40%

Refusal Volume

50.4×30%

Recency

0.0×20%

Frequency

51.5×10%

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

Violation Summary

34117×

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).

50812×

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.

11811×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

1265×

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.

472×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

Date	Product	Violations	Division
1/13/2006	84GYBMEDIA, ELECTROCONDUCTIVE	118NOT LISTED 508NO 510(K)	Minneapolis District Office (MIN-DO)
1/13/2006	84GYBMEDIA, ELECTROCONDUCTIVE	118NOT LISTED 508NO 510(K)	Minneapolis District Office (MIN-DO)
1/13/2006	84GYBMEDIA, ELECTROCONDUCTIVE	118NOT LISTED 508NO 510(K)	Minneapolis District Office (MIN-DO)
12/8/2005	74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE	508NO 510(K)	Minneapolis District Office (MIN-DO)
12/1/2005	74DPSELECTROCARDIOGRAPH	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/30/2005	74DRKDC-DEFIBRILLATOR, HIGH ENERGY, (INCLUDING PADDLES)	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/20/2005	90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC	341REGISTERED	Division of Southeast Imports (DSEI)
8/19/2005	90IZLSYSTEM, X-RAY, MOBILE	341REGISTERED 47NON STD	Florida District Office (FLA-DO)
8/15/2005	90IZLSYSTEM, X-RAY, MOBILE	341REGISTERED 47NON STD	Florida District Office (FLA-DO)
7/14/2004	74DXQCUFF, BLOOD-PRESSURE	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/14/2004	74DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
5/20/2004	74MLOELECTROCARDIOGRAPH, AMBULATORY WITH ANALYSIS ALGORITHM	341REGISTERED	Florida District Office (FLA-DO)
5/20/2004	74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)	341REGISTERED	Florida District Office (FLA-DO)
12/3/2003	74LDDDC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)	118NOT LISTED 508NO 510(K)	Minneapolis District Office (MIN-DO)
9/11/2002	73BZQMONITOR, BREATHING FREQUENCY	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
9/11/2002	73BZQMONITOR, BREATHING FREQUENCY	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
9/11/2002	73BZQMONITOR, BREATHING FREQUENCY	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
10/8/2001	74DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)	118NOT LISTED 126FAILS STD 341REGISTERED	Cincinnati District Office (CIN-DO)
10/8/2001	74DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)	118NOT LISTED 126FAILS STD 341REGISTERED	Cincinnati District Office (CIN-DO)
10/8/2001	74DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)	118NOT LISTED 126FAILS STD 341REGISTERED	Cincinnati District Office (CIN-DO)
10/8/2001	74DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)	118NOT LISTED 126FAILS STD 341REGISTERED	Cincinnati District Office (CIN-DO)
10/8/2001	74DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)	118NOT LISTED 126FAILS STD 341REGISTERED	Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Ge Medical's FDA import refusal history?

Ge Medical (FEI: 3003225744) has 22 FDA import refusal record(s) in our database, spanning from 10/8/2001 to 1/13/2006.

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's FEI number is 3003225744.

What types of violations has Ge Medical received?

Ge Medical has been cited for 5 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 come from?

All FDA import refusal data for Ge Medical 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.