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

GCJ 2016-06-24

Single Use Surgical Suction Irrigator

Applicant Jiangsu Haize Medical Scientific Development Co., Ltd.

K-Number K161421

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NBW 2016-06-24

SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System

Applicant Sd Biosensor

K-Number K153201

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NBW 2016-06-24

Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System

Applicant Ascensia Diabetes Care U.S., Inc.

K-Number K160430

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HGX 2016-06-24

Naya Breast Pump System

Applicant Naya Health, Inc.

K-Number K160511

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MSX 2016-06-24

CareEvent inclusive of the CareEvent Mobile Application accessory

Applicant Philips Medical Systems

K-Number K161164

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HGI 2016-06-24

Liger Medical HTU-110

Applicant Liger Medical, LLC

K-Number K152843

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PNV 2016-06-24

Resmon PRO FULL

Applicant Medical Graphics Corp.

K-Number K152585

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IYE 2016-06-24

iDMS Data Management System

Applicant Accuray Incorporated

K-Number K161144

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BZE 2016-06-23

FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM

Applicant Flexicare Medical Limited.

K-Number K160540

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LGZ 2016-06-23

QiF Blood and Fluid Warmer

Applicant Quality IN Flow , Ltd.

K-Number K150404

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LOX 2016-06-23

Chocolate XD PTCA Balloon Catheter

Applicant Trireme Medical, LLC

K-Number K153682

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JDI 2016-06-23

FitRite Total Hip Arthroplasty System

Applicant Excera Orthopedics, Inc.

K-Number K153057

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