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

NUC 2018-02-05

Flip Lube

Applicant Imquest Biosciences, Inc.

K-Number K171516

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IYN 2018-02-05

RS85 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K173204

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QEW 2018-02-05

FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter

Applicant Inari Medical

K-Number K173672

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NFT 2018-02-05

First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana

Applicant W.H.P.M., Inc.

K-Number K171695

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GBM 2018-02-02

SpeediCath Flex Coude Pro

Applicant Coloplast

K-Number K180070

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OMP 2018-02-02

PICO 7 Single Use Negative Pressure Wound Therapy System

Applicant Smith & Nephew Medical Limited

K-Number K172005

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EOB 2018-02-02

KARL STORZ Slim Nasopharyngolaryngoscope

Applicant KARL STORZ Endoscopy-America, Inc.

K-Number K171402

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JWH 2018-02-02

Materialise TKA Guide System

Applicant Materialise NV

K-Number K173445

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IYN 2018-02-02

ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc. Ultrasound Group

K-Number K173981

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MAX 2018-02-02

The Plateau-LO Spacer System

Applicant Life Spine, Inc.

K-Number K172105

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DJC 2018-02-02

OralTox Oral Fluid Drug Test

Applicant Premier Biotech, Inc.

K-Number K171403

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MBH 2018-02-02

Triathlon Total Knee System

Applicant Stryker Orthopaedics

K-Number K173849

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