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

LZA 2016-04-01

Powder Free Blue Nitrile Examination Glove

Applicant Vietglove Corporation

K-Number K153562

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IYN 2016-04-01

X5 Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K160258

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MWP 2016-04-01

BioVision Plus

Applicant Faxitron Bioptics, LLC

K-Number K153583

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JAK 2016-04-01

Aquilion Lightning, TSX-035A/4 and /5, V7.0

Applicant Toshibamedical Systems Corporation

K-Number K153263

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PCH 2016-04-01

FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch

Applicant Biofire Diagnostics, LLC

K-Number K160459

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EBF 2016-04-01

Pulpdent Solo Flowable Composite with MCP

Applicant Pulpdent Corporation

K-Number K153249

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JOW 2016-04-01

PlasmaFlow

Applicant Manamed, Inc.

K-Number K160318

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HAW 2016-04-01

Fiagon Navigation System

Applicant Fiagon GmbH

K-Number K151156

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PHL 2016-04-01

Ekso (version 1.1) and Ekso GT (version 1.2)

Applicant Ekso Bionics, Inc.

K-Number K143690

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HSB 2016-03-31

PRECICE Trauma Nail System

Applicant Ellipse Technologies, Incorporated

K-Number K160267

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GCJ 2016-03-31

NOVATECH TALCAIR

Applicant Novatech SA

K-Number K151832

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LRK 2016-03-31

SICAT OPTISLEEP

Applicant Sicat GmbH & Co. KG

K-Number K153291

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