Aesculap AG
⚠️ High Risk
FEI: 3002806315 • Tuttlingen, Baden-Wurttemberg • GERMANY
FEI Number
3002806315
Location
Tuttlingen, Baden-Wurttemberg
Country
GERMANYAddress
Am Aesculap-Platz 1, , Tuttlingen, 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
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).
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).
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).
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.
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 |
|---|---|---|---|
| 10/31/2025 | 78FETTAPE, TELEVISION & VIDEO, CLOSED-CIRCUIT, USED DURING ENDOSCOPIC PROCEDURE | Division of Southeast Imports (DSEI) | |
| 3/16/2011 | 87KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/16/2011 | 87KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/16/2011 | 87MJOPROSTHESIS, INTERVERTEBRAL DISC | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/16/2011 | 87MJOPROSTHESIS, INTERVERTEBRAL DISC | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/16/2011 | 87MJOPROSTHESIS, INTERVERTEBRAL DISC | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/16/2011 | 87JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/16/2011 | 87JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/16/2011 | 87JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/16/2011 | 87JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/16/2011 | 87LWJPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/16/2011 | 87LWJPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/16/2011 | 87LWJPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/16/2011 | 87LWJPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/16/2011 | 87LWJPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/16/2011 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/16/2011 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 8/15/2003 | 78KOGENDOSCOPE AND/OR ACCESSORIES | Florida District Office (FLA-DO) | |
| 2/3/2003 | 79MGOCLOSURE, WOUND, ADHESIVE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/27/2002 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/29/2002 | 80LDQDEVICE, GENERAL MEDICAL | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 5/20/2002 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 2/9/2002 | 66VSM99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Aesculap AG's FDA import refusal history?
Aesculap AG (FEI: 3002806315) has 23 FDA import refusal record(s) in our database, spanning from 2/9/2002 to 10/31/2025.
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. Aesculap AG's FEI number is 3002806315.
What types of violations has Aesculap AG received?
Aesculap AG 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 Aesculap AG come from?
All FDA import refusal data for Aesculap 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.