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

DQY 2017-07-25

Rubicon 14, 18 and 35 Support Catheters

Applicant Boston Scientific Corporation

K-Number K171913

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OBP 2017-07-25

MagVita TMS Therapy System

Applicant Tonica Elektronik A/S

K-Number K171967

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KGN 2017-07-25

CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle

Applicant Strukmyer Medical

K-Number K171645

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GEX 2017-07-25

LightMed Dental Laser System

Applicant Lightmed Dentaltechnology Corp.

K-Number K170073

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MUJ 2017-07-25

Radiance V4

Applicant Gmv Soluciones Globales Internet S.A.U.

K-Number K171885

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GEX 2017-07-25

Monteris Medical NeuroBlate System

Applicant Monteris Medical, Inc.

K-Number K171255

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FRO 2017-07-25

PHMB Antimicrobial Foam Wound Dressing

Applicant Advanced Medical Solutions, Ltd.

K-Number K163062

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PND 2017-07-25

CT Midline

Applicant Medical Components, Inc. (dba MedComp)

K-Number K170770

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IYE 2017-07-25

TomoTherapy Treatment Delivery System with iDMS

Applicant Accuray Incorporated

K-Number K171837

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DQK 2017-07-25

CARTO 3 EP Navigation System, Version 6.0 and Accessories

Applicant Biosense Webster, Inc.

K-Number K170600

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HRS 2017-07-24

ARIX Diaphysis System

Applicant Jeil Medical Corporation

K-Number K171285

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JDR 2017-07-24

JAWS(TM) Nitinol Staple System

Applicant Paragon 28

K-Number K170923

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