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

GAT 2020-10-02

Arthrex SoftStitch

Applicant Arthrex, Inc.

K-Number K190707

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ORY 2020-10-02

Encore System

Applicant Siesta Medical, Inc.

K-Number K201238

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FLL 2020-10-02

Infrared Thermometer Model E127

Applicant Bioland Technology, Ltd.

K-Number K201161

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HSB 2020-10-01

TELEGRAPH® EVOLUTION Humeral Nailing System

Applicant FH Industrie

K-Number K200127

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PIF 2020-10-01

Nutricare Clear-ISOSAF Nasogastric Feeding Tube

Applicant Three Circles Consulting Limited

K-Number K202357

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CEM 2020-10-01

SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+

Applicant Diamond Diagnostics, Inc.

K-Number K200544

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FLL 2020-10-01

Infrared PT2L Digital No-Touch Thermometer

Applicant Andon Health Co, Ltd.

K-Number K200710

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HGX 2020-10-01

Philips Avent Single/Double electric breast pump Advanced

Applicant Philips Consumer Lifestyle - Innovation Site Eindhoven

K-Number K201381

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DQK 2020-10-01

HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module

Applicant Edwards Lifesiences, LLC

K-Number K201446

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HRX 2020-10-01

MectaScope System

Applicant Medacta International S.A.

K-Number K200067

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DSA 2020-10-01

ECG Cables and Leadwires

Applicant Xinkang Medical Instrument Co. , Ltd.

K-Number K201359

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PLL 2020-09-30

EverLift Submucosal Lifting Agent

Applicant Gi Supply, Inc.

K-Number K202376

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