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

KNW 2018-10-18

Medax Biopsy Systems III

Applicant Medax Srl Unipersonale

K-Number K181803

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DTX 2018-10-18

Quantum Ventilation Module

Applicant Spectrum Medical , Ltd.

K-Number K181942

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CHH 2018-10-18

Extended Lipid Panel Assay

Applicant Laboratory Corporation of America Holdings

K-Number K181373

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PIF 2018-10-18

Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit

Applicant Xeridiem Medical Devices, A Spectrum Plastics Group Company

K-Number K180708

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NKB 2018-10-18

OLYMPIC Posterior Spinal Fixation System

Applicant Astura Medical, LLC

K-Number K182239

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PGY 2018-10-18

RadiForce RX360, RX360-AR

Applicant Eizo Corporation

K-Number K182591

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NEY 2018-10-18

Swift System

Applicant Emblation , Ltd.

K-Number K181941

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DKZ 2018-10-18

QuickScreen Pro Multi Drug Screening Test, Model 9395Z

Applicant Phamatech, Inc.

K-Number K181945

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BTT 2018-10-18

TNI softFlow 50

Applicant Tni Medical AG

K-Number K180474

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MQB 2018-10-18

14HK701G-W

Applicant Lg Electronics.Inc

K-Number K182348

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GEX 2018-10-17

Youlaser CO2

Applicant Quanta System Spa

K-Number K182669

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HSB 2018-10-17

OsteoBridge IDSF System

Applicant Merete GmbH

K-Number K181026

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