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

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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LZA 2016-03-31

Halyard Black-Orange Powder-Free Nitrile Exam Glove

Applicant Halyard Health

K-Number K153708

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HRX 2016-03-31

Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing

Applicant Stryker Corporation

K-Number K151932

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LZA 2016-03-31

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)

Applicant Hartalega NGC Sdn. Bhd.

K-Number K151997

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OAS 2016-03-31

NewTom VGi evo

Applicant Qr S.R.L.

K-Number K151612

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NHA 2016-03-31

Abutment for Bridges

Applicant Altatec GmbH

K-Number K153779

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LNH 2016-03-31

ECHELON Oval V 5.1 MRI System

Applicant Hitachi Medical Systems America, Inc.

K-Number K153547

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