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

PGY 2016-02-25

DIVA ZSP2105CMI with QUBYX PerfectLum bundle

Applicant The Linden Group Corp

K-Number K160328

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OBJ 2016-02-25

OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)

Applicant Boston Scientific Corporation

K-Number K153617

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LHN 2016-02-25

McLaren Proton Therapy System

Applicant Mclaren Health Care Corporation

K-Number K160063

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PSZ 2016-02-24

BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

Applicant Becton, Dickinson & CO

K-Number K160161

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MAX 2016-02-24

SpineView X-Pac Expandable Lumbar Cage System

Applicant Spine View, Inc.

K-Number K152539

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FEQ 2016-02-24

EndoChoice Water Bottle Cap System

Applicant Endochoice, Inc.

K-Number K153588

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KHS 2016-02-24

Liquid CO2-2 (LCO2-2)

Applicant Randox Laboratories, Ltd.

K-Number K152085

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OHS 2016-02-24

Strialite

Applicant Centre Light Solutions, LLC

K-Number K151337

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FJK 2016-02-24

Oxyless Blood Tubing Set

Applicant Oxyless, Ltd.

K-Number K150304

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DRA 2016-02-24

HeartLight Deflectable Sheath

Applicant Cardiofocus, Inc.

K-Number K152310

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JHI 2016-02-24

Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip

Applicant Assure Tech. Co., Ltd.

K-Number K152768

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KZA 2016-02-24

IV-eye

Applicant Novarix Limited

K-Number K152088

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