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

EIH 2016-03-25

MSCB-001

Applicant GC America, Inc.

K-Number K152274

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NGZ 2016-03-25

VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)

Applicant bioMerieux, Inc.

K-Number K151923

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BWF 2016-03-25

VibraPEP

Applicant Medica Holdings, LLC

K-Number K153441

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JDI 2016-03-25

Corin TaperFit Hip Stem

Applicant Corin U.S.A. Limited

K-Number K153725

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MEG 2016-03-25

U&U Insulin Syringe with/without Safety Retractable Device

Applicant U&U Medical Technology Co, Ltd.

K-Number K152808

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HRS 2016-03-25

Align Anterior Ankle Fusion Plate

Applicant Extremity Medical, LLC

K-Number K160191

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GEH 2016-03-25

truFreeze System

Applicant Csa Medial, Inc.

K-Number K160273

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KNW 2016-03-25

Corvocet Biopsy System

Applicant Merit Medical Systems, Inc.

K-Number K153337

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JWH 2016-03-25

Optetrak Logic Metaphyseal Cones

Applicant Exactech, Inc.

K-Number K153595

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DXT 2016-03-25

DeRoyal Angiography Kits

Applicant Deroyal Industries, Inc.

K-Number K152978

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MAI 2016-03-24

Arthrex SwiveLock Anchors

Applicant Arthrex, Inc.

K-Number K151342

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KTT 2016-03-24

X-Fix Line Additions

Applicant Vilex IN Tennessee, Inc.

K-Number K151881

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