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

MQV 2017-04-18

NovoGro

Applicant Osteonovus, Inc.

K-Number K162087

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GDW 2017-04-18

ECHELON CIRCULAR Powered Stapler

Applicant Ethicon Endo-Surgery, LLC

K-Number K163523

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DQO 2017-04-18

Plato MICROCATH 27B Microcatheter

Applicant Scientia Vascular, LLC

K-Number K170406

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PTE 2017-04-18

EndoRotor

Applicant Interscope, Inc.

K-Number K170120

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BTA 2017-04-18

Model 330 Multifunction Aspirator

Applicant ZOLL Medical Corporation

K-Number K170533

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OLO 2017-04-18

Mako Total Hip Application

Applicant Mako Surgical Corp.

K-Number K170593

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OKS 2017-04-18

Lacriflow CL

Applicant Kaneka Pharma America, LLC

K-Number K170247

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PTF 2017-04-18

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

Applicant Diazyme Laboratories

K-Number K162297

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OMP 2017-04-18

PICO Single Use Negative Pressure Wound Therapy System

Applicant Smith & Nephew Medical Limited

K-Number K163387

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LZG 2017-04-18

OmniPod Insulin Management System

Applicant Insulet Corporation

K-Number K162296

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DXN 2017-04-18

Finapres Nova Noninvasive Hemodynamic Monitor

Applicant Finapres Medical Systems B.V.

K-Number K160967

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LZU 2017-04-17

Soft Plug Extended Duration 180 Canalicular Plug

Applicant Oasis Medical, Inc.

K-Number K162361

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