Panels › Ear, Nose, Throat › Product code MIC · Class 2

Implant, Muscle, Pectoralis

Regulation 874.3620

0510(k)s in 12 months (8 all time)

1recalls in 12 months (1 all time)

1recalls that name a 510(k)

Top companies in MIC

Company	510(k)s	Recalls
Seare Biomedical Corp.	2	0
Aesthetic and Reconstructive Technologies, Inc.	1	0
Applied Biomaterial Technologies	1	0
DSAART LLC	0	1
Hanson Medical, Inc.	1	0
Pillar Surgical, Inc.	1	0
Rand Scientific Corp.	1	0
Spectrum Designs, Inc.	1	0

Date	Firm and product	Code	Linked 510(k)
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

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