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

PPT 2019-07-26

KLS Martin Individual Patient Solutions (IPS) Planning System

Applicant KLS-Martin L.P.

K-Number K182889

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JWH 2019-07-25

Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer

Applicant Osteoremedies, LLC

K-Number K183017

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DWM 2019-07-25

Passio Pump Drainage System

Applicant Bearpac Medical

K-Number K190292

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MXK 2019-07-25

Galilei G6 Lens Professional

Applicant Sis Ag, Surgical Instrument Systems

K-Number K182659

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KDI 2019-07-25

PrisMax System Version 2

Applicant Baxter Healthcare Corp

K-Number K190910

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LQR 2019-07-25

Stonetome Stone Removal Device

Applicant Boston Scientific Corporation

K-Number K191789

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NTE 2019-07-25

Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires

Applicant Abbott Vascular

K-Number K191173

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MBI 2019-07-25

RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant

Applicant Medos International SARL

K-Number K190774

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MAX 2019-07-25

Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage

Applicant Stryker Spine

K-Number K183249

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EBW 2019-07-25

Maxima Electric System

Applicant Handpiece Headquarters - Hpr, Inc.

K-Number K180845

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FRO 2019-07-25

Silicone PHMB Foam Wound Dressing

Applicant Advanced Medical Solutions, Ltd.

K-Number K190819

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HSX 2019-07-25

JOURNEY II Unicompartmental Knee System

Applicant Smith & Nephew, Inc.

K-Number K191211

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