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

FZP 2016-02-26

Vesocclude Polymer Ligating Clip

Applicant Vesocclude Medical, LLC

K-Number K152082

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HWC 2016-02-26

Tyber Medical Trauma Screw

Applicant Tyber Medical, LLC

K-Number K153575

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MDB 2016-02-25

BD BACTEC Peds Plus/F Culture Vials (plastic)

Applicant Becton, Dickinson and Company

K-Number K151866

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HWC 2016-02-25

SIGN Compression Screw System

Applicant Sign Fracture Care International

K-Number K153759

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MAX 2016-02-25

Cogent Lateral Interbody System

Applicant Cogent Spine, LLC

K-Number K151406

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JAD 2016-02-25

Axxent Electronic Brachytherapy System Model 110 XP 1200

Applicant Icad, Inc.

K-Number K153570

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BTR 2016-02-25

ETView VivaSight-SL (TVT) system

Applicant Etview , Ltd.

K-Number K152438

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IYN 2016-02-25

Voluson S6, Voluson S8, Voluson S10

Applicant GE Healthcare

K-Number K160184

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KNW 2016-02-25

Mammotome revolve Dual Vacuum Assist Biopsy System

Applicant Devicor Medical Products, Inc.

K-Number K152989

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HRS 2016-02-25

IRENE Locking Compression Plate System

Applicant Tianjin Zhengtian Medical Instrument Co., Ltd.

K-Number K151508

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GEX 2016-02-25

SKIN CARE

Applicant C.I.S, Ltd.

K-Number K152736

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LYY 2016-02-25

LATEX EXAMINATION GLOVE POWDER FREE

Applicant Careplus (M) Sdn Bhd

K-Number K152593

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