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

GEX 2024-02-14

Azure

Applicant Daeshin Enterprise Co., Ltd.

K-Number K231514

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IYN 2024-02-13

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

Applicant Philips Ultrasound, LLC

K-Number K233788

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LQY 2024-02-13

Apex Locator

Applicant Cefla S.C.

K-Number K231990

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MQB 2024-02-13

EXPD 4343S

Applicant DRTECH Corporation

K-Number K232082

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NKB 2024-02-13

M.U.S.T. Pedicle Screw System - Extension

Applicant Medacta International S.A.

K-Number K234048

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OWT 2024-02-13

Transorb Self-Gripping Resorbable Mesh

Applicant Sofradim Production

K-Number K233661

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KRD 2024-02-13

Easi-Vue® embolic microspheres System

Applicant Abk Biomedical, Inc.

K-Number K234123

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ELW 2024-02-13

Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu

Applicant B&E Korea Co., Ltd.

K-Number K233954

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LZA 2024-02-13

Black Nitrile Powder Free Patient Examination Glove, Non Sterile

Applicant W.A. Rubbermate Co., Ltd.

K-Number K233740

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MQP 2024-02-13

VerteLoc Spinal System

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K231134

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QKB 2024-02-13

QOCA® image Smart RT Contouring System

Applicant Quanta Computer, Inc.

K-Number K231855

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DYB 2024-02-13

EPi-Ease Epicardial Access Device (EAS)

Applicant AtriCure, Inc.

K-Number K233959

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