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

OLZ 2016-12-01

RemLogic

Applicant Embla Systems

K-Number K162140

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JFP 2016-12-01

EasyLyte Na/K/Cl/Ca Analyzer

Applicant Medica Corporation

K-Number K152327

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GEI 2016-12-01

Voyant Open Fusion Device

Applicant Applied Medical Resources

K-Number K162676

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PGW 2016-12-01

Fiagon Navigation System

Applicant Fiagon GmbH

K-Number K162176

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FPA 2016-11-30

Solution Set for Epidural Use

Applicant Baxter Healthcare Corporation

K-Number K161323

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LPL 2016-11-30

DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives

Applicant Alcon Laboratories, Inc.

K-Number K161391

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MTJ 2016-11-30

HEMASORBPLUS Resorbable Hemostatic Bone Putty

Applicant Orthocon, Inc.

K-Number K153317

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MOS 2016-11-30

TxRx Knee 15 Flare MR Coil 1.5T

Applicant Quality Electrodynamics, LLC

K-Number K162966

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OTK 2016-11-30

PleuraFlow System with FlowGlide

Applicant Clearflow, Inc.

K-Number K163139

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DXH 2016-11-30

SimplECG

Applicant Nanowear, Inc.

K-Number K161431

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KNT 2016-11-30

TubeClear Control Box and Clearing Stem

Applicant Actuated Medical, Inc.

K-Number K163092

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OLP 2016-11-30

ESPADA Acne-Clearing Blue Light Pen

Applicant Foreo, Inc.

K-Number K162450

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