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

FPA 2016-04-07

BD FlowSmart Set, MiniMed Pro-Set

Applicant Becton, Dickinson and Company

K-Number K160651

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DYB 2016-04-07

transGlide Expandable Introducer

Applicant Transaortic Medical, Inc.

K-Number K152194

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PGW 2016-04-07

EM ENT Navigated Suctions

Applicant Medtronic Navigation, Inc.

K-Number K153555

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MOF 2016-04-07

ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)

Applicant Asahi Intecc Co., Ltd.

K-Number K160659

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LCX 2016-04-07

Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test

Applicant Sugentech, Inc.

K-Number K142754

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IYN 2016-04-06

EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System

Applicant Philips Ultrasound, Inc.

K-Number K160807

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FPA 2016-04-06

Extension Set

Applicant B.Braun Medical, Inc.

K-Number K153293

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GEX 2016-04-06

Magma System

Applicant Formatk Systems , Ltd.

K-Number K153566

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HRS 2016-04-06

KLS Martin Thoracic Plating System

Applicant KLS-Martin L.P.

K-Number K153482

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KWS 2016-04-06

SMR 3-Pegs Glenoids

Applicant Lima Corporate S.P.A.

K-Number K153722

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PLK 2016-04-06

Wireless Earlens Light Driven Hearing Aid

Applicant Earlens Corporation

K-Number K153634

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JDQ 2016-04-06

KLS Martin LSS Plating System

Applicant KLS Martin L.P.

K-Number K151983

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