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

GWM 2019-01-11

CereLink ICP Monitor, CereLink ICP Extension Cable

Applicant Integra Lifesciences Corp.

K-Number K183406

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LRK 2019-01-11

SLEEPAPP

Applicant Comfort Acrylics, Inc.

K-Number K182202

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MQB 2019-01-11

DigitalDiagnost C90

Applicant Philips Medical Systems Dmc GmbH

K-Number K182973

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FTC 2019-01-11

UV Phototherapy

Applicant Xuzhou Kernel Medical Equipment Co., Ltd.

K-Number K181805

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DQX 2019-01-11

Roadrunner Extra Support Wire Guide

Applicant Cook Incorporated

K-Number K183467

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KIF 2019-01-11

MTA2.3 MATERIALS

Applicant NuSmile, Ltd.

K-Number K181917

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LCX 2019-01-10

Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream

Applicant Weihai Kangzhou Biotechnology Engineering Co., Ltd.

K-Number K183097

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FIP 2019-01-10

DIASAFEplusUS

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K182367

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HTY 2019-01-10

OSSIO Pin Product Family

Applicant OSSIO , Ltd.

K-Number K181180

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FLL 2019-01-10

Advocate Non-Contact Infrared Thermometer

Applicant Broadmaster Biotech, Corp.

K-Number K180355

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MQR 2019-01-10

HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)

Applicant M.I.Tech Co., Ltd.

K-Number K183616

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OMP 2019-01-10

RENASYS Y-Connector; RENASYS TOUCH

Applicant Smith & Nephew Medical Limited

K-Number K181204

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