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

OHS 2016-02-25

Perfectio LED infrared device

Applicant Omm Imports Inc Dba Zero Gravity

K-Number K152332

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PSZ 2016-02-25

BD Veritor System for Rapid Detection of Flu A + B Labratory Kit

Applicant Becton, Dickinson & CO

K-Number K160164

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MWI 2016-02-25

VITAL SIGNS MONITOR

Applicant Guangdong Biolight Meditech Co., Ltd.

K-Number K153135

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LLZ 2016-02-25

IMPLANT 3D

Applicant Media Lab S.R.L.

K-Number K153091

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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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