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

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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HSD 2024-02-12

Univers Revers CA Head and Adapter

Applicant Arthrex, Inc.

K-Number K233260

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MLY 2024-02-12

PainFreeze II

Applicant Nuance Medical, LLC

K-Number K232674

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JXI 2024-02-12

NerveTape

Applicant Biocircuit Technologies, Inc.

K-Number K233533

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NUH 2024-02-12

Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)

Applicant Chongqing Rob Linka Science and Technology Co., Ltd.

K-Number K233092

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NEU 2024-02-12

SCOUT MD Surgical Guidance System

Applicant Merit Medical System, Inc.

K-Number K231468

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HIH 2024-02-12

SPY Cystoscope/Hysteroscope

Applicant Stryker Endoscopy

K-Number K233635

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