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

MNI 2016-02-26

Sniper (R) Spine System

Applicant Spine Wave, Inc.

K-Number K160003

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EWY 2016-02-26

Illuminated Mediastinal Access Port

Applicant Aegis Surgical, Ltd.

K-Number K160171

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IYN 2016-02-26

E-CUBE i7

Applicant Alpinion Medical Systems Co., Ltd.

K-Number K153424

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EBF 2016-02-26

Calcium Bridge

Applicant Denali Corporation

K-Number K153191

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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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