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

FRO 2016-10-03

Dynarex Xeroform Petrolatum Dressing

Applicant Dynarex Corporation

K-Number K152970

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IYN 2016-10-03

Lumify Ultrasound System

Applicant Philips Health Care

K-Number K162549

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IYN 2016-10-03

Voluson E6, Voluson E8, Voluson E10

Applicant GE Healthcare

K-Number K162269

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MQB 2016-10-03

SKR 3000

Applicant Konica Minolta, Inc.

K-Number K162504

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LDR 2016-10-03

Volumetric Infusion Controller

Applicant DEKA Research & Development

K-Number K153760

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OAS 2016-10-03

PreXion3D Excelsior

Applicant Prexion Corporation

K-Number K161881

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IYN 2016-10-03

RS80A Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K153539

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OCC 2016-10-03

FilmArray Respiratory Panel EZ (RP EZ)

Applicant Biofire Diagnostics, LLC

K-Number K152579

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LLZ 2016-10-03

kneeEOS

Applicant Onefit Medical

K-Number K161828

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PBX 2016-10-03

Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care

Applicant Indiba USA, Inc.

K-Number K161458

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JAQ 2016-10-02

Esophagus Bougie Set

Applicant Varian Medical Systems, Inc.

K-Number K161576

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MXJ 2016-10-01

SeraQuest Herpes Type 1 Specific IgG

Applicant Quest International, Inc.

K-Number K162276

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