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

HQD 2016-02-09

BostonSight IC Corneal Lens, BostonSight IC Scleral Lens

Applicant Boston Foundation For Sight

K-Number K153066

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HRS 2016-02-09

Epic Extremity Plate System

Applicant Epic Extremity, LLC

K-Number K153340

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KCT 2016-02-08

M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)

Applicant Microline Surgical, Inc.

K-Number K152743

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GAT 2016-02-08

ExpressBraid Graft Manipulation

Applicant Biomet Manufacturing Corp

K-Number K152868

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FBK 2016-02-08

EndoChoice Select Injection Needle

Applicant Endochoice, Inc.

K-Number K151475

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OCC 2016-02-08

FilmArray Respiratory Panel (RP) for use with FilmArray Torch

Applicant Biofire Diagnostics, LLC

K-Number K160068

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HWC 2016-02-05

MINIARS SCREWS

Applicant Overmed Srl.

K-Number K143596

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DPS 2016-02-05

PC ECG

Applicant Edan Instruments, Inc.

K-Number K152427

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FRO 2016-02-05

AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC)

Applicant Abl Medical, LLC

K-Number K151185

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DSI 2016-02-05

Vital Signs Patch System

Applicant Lifewatch Technologies , Ltd.

K-Number K151835

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LYZ 2016-02-05

Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue

Applicant Zibo Huiying Medical Products, Co. , Ltd.

K-Number K153028

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LXJ 2016-02-05

YuGo System

Applicant Biogaming , Ltd.

K-Number K151955

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