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

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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LJS 2016-02-05

Amecath Peripheral inserted Central Venous Catheter Sets

Applicant Ameco Medical Industries

K-Number K152819

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FWP 2016-02-05

Stryker CMF MEDPOR Customized Implant

Applicant Stryker

K-Number K153508

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JFB 2016-02-05

N5-1

Applicant Nuga Medical Co., Ltd.

K-Number K153054

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