Company
DSAART LLC
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
6recalls (6 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| 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 Pectoral Implant
Product Name: Pectoral Implant
Model/Catalog Number:
500-106-5 Pectoral Implant style 1 size 6 left
UDI-DI code: B4905001065
500-106-6 Pectoral Implant style 1 size Open, Classified |
MIC | K021337 |
| Dec 18, 2025 | DSAART LLC Brand Name: AART Malar Implant
Product Name: Malar Implant
Model/Catalog Number:
401-202-5 Malar Implant style 2 size 2 left
UDI-DI code: B4904012025
401-202-6 Malar Implant style 2 size 2 right
UDI- Open, Classified |
LZK | K021419 |
| Dec 18, 2025 | DSAART LLC Brand Name: AART Chin Implant
Product Name: Chin Implant
Model/Catalog Numbers:
400-0101 Chin Implant style 1 size 1
UDI-DI code: B490400101
400-0103 Chin Implant style 1 size 3
UDI-DI code: B4904001 Open, Classified |
FWP | K021417 |
| 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 |