Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

EBZ 2023-08-04

CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)

Applicant Good Doctors Co., Ltd.

K-Number K223507

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GCJ 2023-08-04

Bladeless Trocar – Artemis Lap Cannula

Applicant T.A.G. Medical Products Corporation, Ltd.

K-Number K231400

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GKA 2023-08-04

Premier Resolution System

Applicant Trinity Biotech (Primus Corporation, Dba Trinity Biotech)

K-Number K222635

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MBI 2023-08-04

HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid)

Applicant Smith & Nephew, Inc.

K-Number K232005

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DQK 2023-08-04

ECGenius System

Applicant Cath Vision Aps

K-Number K223787

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MBI 2023-08-04

T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button

Applicant Healthium Medtech Limited

K-Number K231404

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JOW 2023-08-04

LEGACY® IPC

Applicant Ig Technology, Ltd.

K-Number K232006

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MQL 2023-08-04

Dewin Blastocyst Medium (with HSA and without HSA)

Applicant Donnevie Medical Technology (Shanghai) Co. , Ltd.

K-Number K231370

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JDR 2023-08-03

Extremity Staple

Applicant Restor3D

K-Number K231458

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GAT 2023-08-03

MENIX®; MENIX® DUO

Applicant S.B.M. Sas (Science & Bio Materials)

K-Number K223122

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KFM 2023-08-03

LifeSPARC System

Applicant Cardiacassist, Inc.

K-Number K232132

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BTT 2023-08-03

Sterile Water for Inhalation in 1L Flexoval ® bottles.

Applicant Hometa, Inc.

K-Number K223551

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