MEDICON AG

⚠️ Moderate Risk

FEI: 3012956843 • Tuttlingen, Baden-Wurttemberg • GERMANY

FEI

FEI Number

3012956843

📍

Location

Tuttlingen, Baden-Wurttemberg

🇩🇪

Country

GERMANY

🏢

Address

Postfach 4455, , Tuttlingen, Baden-Wurttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

39.2

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/13/2012

Latest Refusal

10/16/2001

Earliest Refusal

Score Breakdown

Violation Severity

50.7×40%

Refusal Volume

54.2×30%

Recency

0.0×20%

Frequency

27.1×10%

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

11827×

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).

5081×

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

Date	Product	Violations	Division
2/13/2012	74ODLCARDIOVASCULAR	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	78FHIRING, LAPAROTOMY	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	79HCFINSTRUMENT, LIGATURE PASSING AND KNOT TYING	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	79NNABIOSPY DEVICE, PERCUTANEOUS, REPROCESSED	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	79NNABIOSPY DEVICE, PERCUTANEOUS, REPROCESSED	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	79FZSCURETTE, SURGICAL	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	79MXETAPE AND BANDAGE, ADHESIVE (WITH DISINFECTANT)	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	80LBIUNIT, NEONATAL PHOTOTHERAPY	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	79LRQTRACHEOSTOMY AND NASAL SUCTIONING KIT	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	79OVNSUTURE KIT	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	79OEIDRAINAGE CATHETER WITH ANTIBIOTIC	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	79GBXCATHETER, IRRIGATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	80GAZTUBING, NONINVASIVE	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	79OEIDRAINAGE CATHETER WITH ANTIBIOTIC	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	80KZADEVICE, VEIN LOCATION, LIQUID CRYSTAL	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	85KNAINSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	85OHMCESAREAN SECTION KIT	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	79HCFINSTRUMENT, LIGATURE PASSING AND KNOT TYING	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	79HXMRETRACTOR	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	79FZQCLIP, REMOVABLE (SKIN)	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	79GENFORCEPS, GENERAL & PLASTIC SURGERY	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	78KOASURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	79MCZSUTURE REMOVAL KIT	118NOT LISTED	Division of Southeast Imports (DSEI)
2/13/2012	78KOASURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)	118NOT LISTED	Division of Southeast Imports (DSEI)
9/12/2005	85HFXCLAMP, CIRCUMCISION	508NO 510(K)	Chicago District Office (CHI-DO)
10/16/2001	79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL	118NOT LISTED	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is MEDICON AG's FDA import refusal history?

MEDICON AG (FEI: 3012956843) has 28 FDA import refusal record(s) in our database, spanning from 10/16/2001 to 2/13/2012.

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. MEDICON AG's FEI number is 3012956843.

What types of violations has MEDICON AG received?

MEDICON AG 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 MEDICON AG come from?

All FDA import refusal data for MEDICON AG 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.