Panels › Ear, Nose, Throat › Product code MIB · Class 2
Elastomer, Silicone Block
Regulation 874.3620
0510(k)s in 12 months (45 all time)
3recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in MIB
| Company | 510(k)s | Recalls |
|---|---|---|
| Aesthetic and Reconstructive Technologies, Inc. | 4 | 0 |
| Hanson Medical, Inc. | 4 | 0 |
| International Medical Devices, Inc. | 4 | 0 |
| Silimed, Inc. | 4 | 0 |
| Allied Biomedical Corp. | 3 | 0 |
| DSAART LLC | 0 | 3 |
| Specialty Surgical Products, Inc. | 3 | 0 |
| Applied Biomaterial Technologies | 2 | 0 |
| Implantech Associates, Inc. | 2 | 0 |
| Rand Scientific Corp. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2025 | DSAART LLC Brand Name: AART Calf Implant
Product Name: Calf Implant
Model/Catalog Number:
502-103 - Calf Implant style 1 size 3
UDI-DI code: B490502103
502-104 - Calf Implant style 1 size 4
UDI-DI code: B490502 Open, Classified |
MIB | K022511 |
| Dec 18, 2025 | DSAART LLC Brand Name: AART Gluteal Implant
Product Name: Gluteal Implant
Model/Catalog Numbers:
501-101 - Gluteal Implant style 1 size 1
UDI-DI code: B490501101
501-103 - Gluteal Implant style 1 size 3
UDI-DI Open, Classified |
MIB | K021839 |
| Dec 18, 2025 | DSAART LLC Brand Name: AART Silicone Carving Implant
Product Name: Silicone Carving Implant
Model/Catalog Numbers:
600-601 - Silicone Carving Implant Style 6 Size 1
UDI-DI code: B490600601
600-602 - Silicone Ca Open, Classified |
MIB | K021820 |
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