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

CGZ 2016-12-16

VITROS Chemistry Products Cl- Slides

Applicant Ortho Clinical Diagnostics

K-Number K162020

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GXI 2016-12-16

COOLIEF Cooled Radiofrequency Kit

Applicant Halyard Health, Inc.

K-Number K163236

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JGS 2016-12-16

ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer

Applicant Beckman Coulter, Inc.

K-Number K161837

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KWQ 2016-12-16

CETRA Anterior Cervical Plate System

Applicant Orthofix, Inc.

K-Number K162638

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NHA 2016-12-16

Dentium CAD/CAM Abutments

Applicant Dentium Co., Ltd.

K-Number K161713

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JAK 2016-12-16

Revolution CT

Applicant Ge Medical Systems, LLC

K-Number K163213

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PGY 2016-12-15

6MP Color LCD Monitor, RadiForce RX660, RX660-AR

Applicant Eizo Corporation

K-Number K163335

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ILY 2016-12-15

WS(TM) Far-Infrared Therapy Unit, Model KP-B210

Applicant Ws Far IR Medical Technology Co., Ltd.

K-Number K160849

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GAT 2016-12-15

PERMATAPE

Applicant Medos International SARL

K-Number K162247

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LLZ 2016-12-15

Zia

Applicant Zetta Medical Technologies, LLC

K-Number K160852

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LRK 2016-12-15

BluePro

Applicant Bluesom

K-Number K162192

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NUA 2016-12-15

xTAG Cystic Fibrosis 39 Kit v2

Applicant Luminex Molecular Diagnostics, Inc.

K-Number K163347

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