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

JWH 2016-05-19

EMPOWR PS Knee System

Applicant Encore Medical L.P.

K-Number K160342

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OCY 2016-05-19

EasyPass Guidewire

Applicant Medi-Globe Corporation

K-Number K153264

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EOQ 2016-05-19

Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)

Applicant Prosurg, Inc.

K-Number K152466

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ODC 2016-05-19

SmartStart Air/Water and Suction Valves

Applicant Endochoice, Inc.

K-Number K160403

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HRS 2016-05-19

OsteoMed ExtremiLOCK Wrist Plating System

Applicant Osteomed

K-Number K161041

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OBJ 2016-05-19

OptiCross X, 40 MHz Coronary Imaging Catheter

Applicant Boston Scientific Corporation

K-Number K161125

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GEI 2016-05-19

Valleylab REM Polyhesive Infant Patient Return Electrode

Applicant Covidien, LLC

K-Number K160290

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DYB 2016-05-19

Nanostim Introducer Kit

Applicant St. Jude Medical, Inc.

K-Number K161102

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NEW 2016-05-19

Filbloc

Applicant Assut Europe

K-Number K150553

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BTA 2016-05-18

Vario 8/18/ci

Applicant Medela AG

K-Number K153663

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GCJ 2016-05-18

Stryker SDC3 HD Information Management System with Wireless Device Control Capability

Applicant Stryker Endoscopy

K-Number K160332

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PGY 2016-05-18

Mammo Tomosynthesis (MDMG-5221)

Applicant Barco N.V.

K-Number K161229

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