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

DQX 2017-06-22

Merit Hydrophilic Guide Wire

Applicant Merit Medical Systems, Inc.

K-Number K170933

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FAD 2017-06-22

Tria Firm Ureteral Stent

Applicant Boston Scientific Corporation

K-Number K163399

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MWI 2017-06-22

CoVa Monitoring System 2

Applicant Tosense, Inc.

K-Number K160899

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CCW 2017-06-22

Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)

Applicant Girgis Scope, LLC

K-Number K163412

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KGO 2017-06-22

Sterile Polyisoprene Powder Free Surgical Gloves

Applicant Better Care Plastic Technology Co., Ltd.

K-Number K171047

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DSA 2017-06-22

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System

Applicant Carefusion 303, Inc.

K-Number K163316

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POM 2017-06-21

ImPACT Quick Test

Applicant Impact Applications, Inc.

K-Number K170551

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MQB 2017-06-21

BSD4343R Digital Flat Panel X-ray Detector

Applicant Bontech, Inc.

K-Number K171485

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NBY 2017-06-21

GOLNIT Non-Absorbable PTFE Surgical Suture

Applicant Antarma Dba Golnit Sutures

K-Number K163049

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FTM 2017-06-21

Biodesign Fistula Plug

Applicant Cook Biotech Incorporated

K-Number K170016

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OBO 2017-06-21

PRIMUS

Applicant Carl Zeiss Suzhou Co., Ltd.

K-Number K163195

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IZL 2017-06-21

DRX-Revolution Nano Mobile X-ray System

Applicant Carestream Health, Inc.

K-Number K170755

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