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 2016-02-23

2MP Color LCD Monitor, RadiForce RX250 and RX250-AR

Applicant Eizo Corporation

K-Number K160247

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HRX 2016-02-22

VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM

Applicant Visionsense, Ltd.

K-Number K153548

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KGN 2016-02-22

PriMatrix Dermal Repair Scaffold

Applicant Tei Biosciences, Inc.

K-Number K153690

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PMT 2016-02-20

B.R.A.H.M.S PCT sensitive KRYPTOR

Applicant Brahms GmbH

K-Number DEN150009

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LHI 2016-02-19

APEX Compounding System Transfer Set

Applicant B.Braun Medical, Inc.

K-Number K151423

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KTI 2016-02-19

ViziShot FLEX

Applicant Spiration, Inc.

K-Number K152922

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GEI 2016-02-19

InMode RF System

Applicant Inmode MD , Ltd.

K-Number K151793

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MBH 2016-02-19

Arthrex iBalance TKA System

Applicant Arthrex, Inc.

K-Number K153586

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JAK 2016-02-19

syngo.CT Single Source Dual Energy (Twin Beam)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K153220

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OMP 2016-02-19

Venturi Gauze Wound Care Sets with Portal Drain

Applicant Talley Group, Ltd.

K-Number K151263

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LCJ 2016-02-19

CPX 4 Breast Tissue Expander

Applicant Mentor Worldwide, LLC

K-Number K152496

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HCG 2016-02-19

InZone Detachment System

Applicant Stryker Neurovascular

K-Number K160096

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