Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

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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GDW 2016-03-24

iMESH Tacker

Applicant Thd Lap

K-Number K153202

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PJJ 2016-03-24

STERIZONE VP4 Sterilizer

Applicant Ts03, Inc.

K-Number K153392

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HRS 2016-03-24

Biomet Microfixation RibFix Blu Thoracic Fixation System

Applicant Biomet Microfixation

K-Number K152253

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BZE 2016-03-24

Hybernite RT

Applicant Plastiflex Group NV

K-Number K151461

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NCX 2016-03-24

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit

Applicant Zoll Circulation, Inc.

K-Number K153226

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MAX 2016-03-24

NuVasive® Lumbar Interbody Implants

Applicant Nu Vasive, Incorporated

K-Number K153782

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DYW 2016-03-24

Exceed Tx

Applicant Great Lakes Orthodontics, Ltd.

K-Number K150702

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