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

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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QFQ 2019-04-12

Plenity

Applicant Gelesis, Inc.

K-Number DEN180060

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DTZ 2019-04-12

Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface

Applicant Medtronic, Inc.

K-Number K183490

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HSB 2019-04-11

Syntec Femoral Nail System

Applicant Syntec Scientific Corporation

K-Number K181296

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FTM 2019-04-11

Endoform Restella

Applicant Aroa Biosurgery , Ltd.

K-Number K183398

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