Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

NEW 2023-03-07

MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014

Applicant Hans Biomed Corporation

K-Number K220549

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QEP 2023-03-07

Visby Medical Sexual Health Test

Applicant Visby Medical

K-Number K220407

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QEB 2023-03-07

Enlight 2100

Applicant Timpel S.A.

K-Number K222897

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NUC 2023-03-07

Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine

Applicant Rb Health (Us), LLC

K-Number K213892

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HRS 2023-03-07

Tyber Medical Anatomical Plating System

Applicant Tyber Medical, LLC

K-Number K222465

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JAK 2023-03-07

Aquilion Precision (TSX-304A/4) V10.14 with AiCE

Applicant Canon Medical Systems Corporation

K-Number K223726

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NEY 2023-03-07

Solero Microwave Tissue Ablation (MTA) System and Accessories

Applicant AngioDynamics, Inc.

K-Number K221883

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FYA 2023-03-07

Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)

Applicant Xiamen Probtain Medical Techology Co., Ltd.

K-Number K223401

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DZJ 2023-03-07

MedCAD AccuPlan System

Applicant Medcad

K-Number K223024

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QEW 2023-03-07

Protrieve Sheath

Applicant Inari Medical, Inc.

K-Number K230331

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FXX 2023-03-06

Procedure mask/Surgical mask/Face mask

Applicant Winner Medical Co., Ltd.

K-Number K223232

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QVN 2023-03-06

Lenire Tinnitus Treatment Device

Applicant Neuromod Devices Limited

K-Number DEN210033

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