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

DXT 2018-02-16

ACISTCVi® Contrast Delivery System

Applicant Acist Medical Systems, Inc.

K-Number K171646

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PCN 2018-02-15

Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit

Applicant The Binding Site Group , Ltd.

K-Number K172613

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GEI 2018-02-15

BOWA Neutral Electrodes

Applicant Bowa-Electronics GmbH & Co. KG

K-Number K173877

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LKF 2018-02-15

Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip

Applicant Cook Incorporated

K-Number K171604

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GEH 2018-02-15

AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)

Applicant AtriCure, Inc.

K-Number K180137

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DYB 2018-02-15

Prelude IDeal Hydrophilic Sheath Introducer

Applicant Merit Medical Systems, Inc.

K-Number K173750

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GAW 2018-02-15

Gazelle Polypropylene Suture and Delivery Device

Applicant Dura Tap, LLC

K-Number K173644

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KHE 2018-02-15

Instant-view-PLUS immunochemical Fecal Occult Blood Test

Applicant Alfa Scientific Designs, Inc.

K-Number K173212

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FYC 2018-02-15

SURGICAL ISOLATION GOWN

Applicant Jingzhou Haixin Green Cross Medical Products Co., Ltd.

K-Number K171535

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DXX 2018-02-15

CorPath GRX System

Applicant Corindus, Inc.

K-Number K173288

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LLZ 2018-02-15

Velocity

Applicant Varian Medical Systems, Inc.

K-Number K173636

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GXH 2018-02-15

AtriCure cryoICE cryo-ablation probe (CRYO2)

Applicant AtriCure, Inc.

K-Number K180138

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