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

JDI 2018-09-28

Libertas Hip Replacement System

Applicant Maxx Orthopedics, Inc.

K-Number K180973

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MAI 2018-09-28

MICRORAPTOR Knotless Suture Anchor

Applicant Smith and Nephew, Inc.

K-Number K181746

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NFJ 2018-09-28

Harmony

Applicant Topcon Medical Systems, Inc.

K-Number K182376

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DXH 2018-09-28

FibriCheck

Applicant Qompium NV

K-Number K173872

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KCT 2018-09-28

Endoscope Sterilization Tray

Applicant Intuitive Surgical, Inc.

K-Number K180964

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MBH 2018-09-28

Truliant Porous Femoral Components

Applicant Exactech, Inc.

K-Number K181794

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KWS 2018-09-27

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)

Applicant Stryker GmbH

K-Number K181742

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GCJ 2018-09-27

Disposable Standard Clamp

Applicant Standard Bariatrics

K-Number K181608

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NQD 2018-09-27

CRP Vario

Applicant SENTINEL CH. SpA

K-Number K173833

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KRD 2018-09-27

EmboCube Embolization Gelatin

Applicant Biosphere Medical, S.A.

K-Number K181021

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NKB 2018-09-27

CarboClear® Pedicle Screw System

Applicant CarboFix Orthopedics , Ltd.

K-Number K182377

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MAX 2018-09-27

DualX

Applicant Innovasive, Inc.

K-Number K181397

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