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

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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FXX 2023-08-03

Surgical Face Masks, Model: EFMDS-L50Pn BLU

Applicant Iris USA

K-Number K230380

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MQB 2023-08-03

YosemiteView 4343W/YosemiteView 3643W

Applicant Careray Digital Medical Technology Co., Ltd.

K-Number K232058

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GEX 2023-08-03

Medical Diode Laser, Model S1Pro

Applicant Wuhan Pioon Technology Co., Ltd.

K-Number K231548

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