Violation Code: 341
FDA Violation
Charge Code: REGISTERED
Violation Details
- Violation Code (ASC ID)
- 341
- Charge Code
- REGISTERED
- Description
- 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).
- Legal Section
- 502(o), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | DreamCon Co. Ltd. | Yangsan, SOUTH KORE | 288 |
| 2 | Voco GmbH | Cuxhaven, GERMANY | 266 |
| 3 | Shanghai Jiu He Import And Export Co. | Shanghai, CHINA | 166 |
| 4 | Nobel Biocare | The Netherlands, NETHERLAND | 134 |
| 5 | EPPENDORF AG | Hamburg, GERMANY | 133 |
| 6 | Tomey Corporation | Nagoya, JAPAN | 126 |
| 7 | Agfa Gevaert NV | Mortsel, BELGIUM | 83 |
| 8 | Nipro Corporation | Osaka, JAPAN | 74 |
| 9 | LINHAISHI WANDA GLASSES FACTORY | LINHAI, CHINA | 68 |
| 10 | Ge Healthcare Logistique France | Cedex, FRANCE | 67 |
| 11 | Stryker Trauma GmbH | Schonkirchen, GERMANY | 65 |
| 12 | Nissho Corporation | Osaka, JAPAN | 63 |
| 13 | Dentech Corp. | Itabashi, JAPAN | 61 |
| 14 | Labtician Ophthalmics Inc. | Oakville, CANADA | 60 |
| 15 | Luxottica Group S.P.A. | AGORDO, ITALY | 54 |
| 16 | Shanghai Neo-Medical Import & Export Co., Ltd. | Shanghai, CHINA | 53 |
| 17 | NIPRO CORP. | Odate, JAPAN | 49 |
| 18 | Elmed Instruments Pvt. Ltd. | Sialkot, PAKISTAN | 48 |
| 19 | Beijing Reagent Latex Products Co., Ltd. | Beijing, CHINA | 48 |
| 20 | K T Surgico (PVT) Ltd. | Sialkot, PAKISTAN | 47 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/22/2026 | FACIAL IMPLANT 79ODU | DENTOLINECOLOMBIA |
| 1/22/2026 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 1/21/2026 | ACCESSORIES, CATHETER, G-U 78KNY | CREGANNA MEDICALSRCOSTA RICA |
| 1/21/2026 | SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC 90IYN | BUTTERFLY NETWORKUNITED STA |
| 1/21/2026 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | VASYL KUTSPORTUGAL |
| 1/21/2026 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | METHODOLOGYSOUTH KORE |
| 1/20/2026 | SUTURE KIT 79OVN | Daesung Enterprise Co., Ltd.SOUTH KORE |
| 1/20/2026 | SUTURE KIT 79OVN | Daesung Enterprise Co., Ltd.SOUTH KORE |
| 1/20/2026 | SUTURE KIT 79OVN | Daesung Enterprise Co., Ltd.SOUTH KORE |
| 1/20/2026 | CANNULA, CATHETER 74DQR | Philtech Co., Ltd.SOUTH KORE |
| 1/20/2026 | MATERIAL, TOOTH SHADE, RESIN 76EBF | ASIGAAUSTRALIA |
| 1/20/2026 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | Exocobio, Inc.SOUTH KORE |
| 1/20/2026 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | BIOPLUS Co., LTDSOUTH KORE |
| 1/20/2026 | OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. 53EL99 | E-FILLERS SAGREECE |
| 1/20/2026 | OTHER SKIN CARE PREPARATIONS, N.E.C. 53LY99 | E-FILLERS SAGREECE |
Related Violations
Other violations under the same legal section: 502(o), 801(a)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 341?
341 is an FDA violation code that indicates: "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).". This violation is based on 502(o), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 341?
According to FDA Import Refusal data, there have been 21690 import refusals issued for violation code 341, affecting 10015 unique firms.
When was the most recent refusal for violation 341?
The most recent import refusal for violation 341 was on January 22, 2026.
What products are commonly refused for violation 341?
Products commonly refused under violation 341 include: FACIAL IMPLANT, SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE), ACCESSORIES, CATHETER, G-U, SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC, IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 341?
Violation code 341 is based on 502(o), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section of the law establishes requirements that imported products must meet to be allowed entry into the United States.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.