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

MOS 2019-04-12

3T 32 Channel Head Coil

Applicant Nova Medical, Inc.

K-Number K182737

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BTY 2019-04-12

Ascent Cardiorespiratory Diagnostic Software

Applicant Medical Graphics Corporation

K-Number K181912

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JAK 2019-04-12

Deep Learning Image Reconstruction

Applicant Ge Medical Systems, LLC

K-Number K183202

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DXH 2019-04-12

KardiaMobile, KardiaStation

Applicant AliveCor, Inc.

K-Number K182396

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HRS 2019-04-12

Baby Gorilla/Gorilla Plating System

Applicant Paragon 28, Inc.

K-Number K190365

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NHB 2019-04-12

PuraSinus

Applicant 3-D Matrix, Inc.

K-Number K183015

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EIH 2019-04-12

ArgenZ HT+

Applicant The Argen Corporation

K-Number K190079

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PEN 2019-04-12

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

Applicant Genmark Diagnostics, Incorporated

K-Number K182619

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LZA 2019-04-12

Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue)

Applicant Shandong Hengya Packaging Printing Co.,Ltd

K-Number K182640

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OWB 2019-04-12

SyncVision System

Applicant Volcano Corporation

K-Number K190626

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HCH 2019-04-12

D-Clip; D-Clip Applier

Applicant Peter Lazic GmbH

K-Number K180757

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OGZ 2019-04-12

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter

Applicant Infraredx, Inc.

K-Number K183599

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