Admedes GmbH
⚠️ High Risk
FEI: 3003956144 • Pforzheim, Baden-Wurttemberg • GERMANY
FEI Number
3003956144
Location
Pforzheim, Baden-Wurttemberg
Country
GERMANYAddress
Rastatter Str. 15, , Pforzheim, Baden-Wurttemberg, Germany
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
3904
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/12/2024 | 79NJUSUTURE, NONABSORBABLE, NITINOL | 39043904 | Division of Southeast Imports (DSEI) |
| 4/12/2024 | 79NJUSUTURE, NONABSORBABLE, NITINOL | 39043904 | Division of Southeast Imports (DSEI) |
| 12/13/2022 | 74PKKSTENT DELIVERY SYSTEM | Division of Southeast Imports (DSEI) | |
| 12/13/2022 | 74PKKSTENT DELIVERY SYSTEM | Division of Southeast Imports (DSEI) | |
| 12/13/2022 | 74PKKSTENT DELIVERY SYSTEM | Division of Southeast Imports (DSEI) | |
| 12/13/2022 | 74PKKSTENT DELIVERY SYSTEM | Division of Southeast Imports (DSEI) | |
| 12/13/2022 | 74PKKSTENT DELIVERY SYSTEM | Division of Southeast Imports (DSEI) | |
| 12/13/2022 | 74PKKSTENT DELIVERY SYSTEM | Division of Southeast Imports (DSEI) | |
| 12/13/2022 | 74PKKSTENT DELIVERY SYSTEM | Division of Southeast Imports (DSEI) | |
| 12/13/2022 | 74PKKSTENT DELIVERY SYSTEM | Division of Southeast Imports (DSEI) | |
| 12/13/2022 | 74PKKSTENT DELIVERY SYSTEM | Division of Southeast Imports (DSEI) | |
| 12/13/2022 | 74PKKSTENT DELIVERY SYSTEM | Division of Southeast Imports (DSEI) | |
| 12/13/2022 | 74PKKSTENT DELIVERY SYSTEM | Division of Southeast Imports (DSEI) | |
| 5/4/2016 | 74NIMSTENT, CAROTID | Division of Southeast Imports (DSEI) | |
| 5/4/2016 | 74NIMSTENT, CAROTID | Division of Southeast Imports (DSEI) | |
| 11/18/2015 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 2/12/2015 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | 237NO PMA | New Orleans District Office (NOL-DO) |
| 2/10/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 2/10/2015 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 2/10/2015 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 2/10/2015 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 2/10/2015 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 2/10/2015 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | New Orleans District Office (NOL-DO) | |
| 2/10/2015 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | New Orleans District Office (NOL-DO) | |
| 2/10/2015 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 1/29/2015 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 1/29/2015 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 1/29/2015 | 74LWRTISSUE, HEART-VALVE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/26/2015 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | New Orleans District Office (NOL-DO) | |
| 1/26/2015 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | New Orleans District Office (NOL-DO) | |
| 1/26/2015 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | New Orleans District Office (NOL-DO) | |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 1/26/2015 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 1/26/2015 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | New Orleans District Office (NOL-DO) | |
| 1/26/2015 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | New Orleans District Office (NOL-DO) | |
| 1/26/2015 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | New Orleans District Office (NOL-DO) | |
| 1/26/2015 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | New Orleans District Office (NOL-DO) | |
| 1/26/2015 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | New Orleans District Office (NOL-DO) | |
| 1/23/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/23/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/23/2015 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 1/23/2015 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 1/23/2015 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 1/23/2015 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 1/23/2015 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 1/23/2015 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 1/21/2015 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/21/2015 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/21/2015 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/16/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/16/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/16/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/16/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/16/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/16/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/16/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/16/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/16/2015 | 74LWRTISSUE, HEART-VALVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/16/2015 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | New Orleans District Office (NOL-DO) | |
| 1/16/2015 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | New Orleans District Office (NOL-DO) | |
| 6/28/2013 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 4/26/2013 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | New Orleans District Office (NOL-DO) | |
| 4/26/2013 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | New Orleans District Office (NOL-DO) | |
| 4/26/2013 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | New Orleans District Office (NOL-DO) | |
| 4/26/2013 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | New Orleans District Office (NOL-DO) | |
| 12/6/2012 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 12/6/2012 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 12/6/2012 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 12/6/2012 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 12/6/2012 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 12/6/2012 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 12/6/2012 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 12/6/2012 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 12/6/2012 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 12/6/2012 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 12/6/2012 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 12/6/2012 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) | |
| 12/6/2012 | 74LWRTISSUE, HEART-VALVE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Admedes GmbH's FDA import refusal history?
Admedes GmbH (FEI: 3003956144) has 113 FDA import refusal record(s) in our database, spanning from 1/4/2011 to 4/12/2024.
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. Admedes GmbH's FEI number is 3003956144.
What types of violations has Admedes GmbH received?
Admedes GmbH 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 Admedes GmbH come from?
All FDA import refusal data for Admedes GmbH 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.