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

NGT 2020-02-13

Praxiject 0.9% NaCl

Applicant Medxl, Inc.

K-Number K192414

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MOI 2020-02-13

ADVIA Centaur BR

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K193489

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IYN 2020-02-12

Leltek Ultrasound Imaging System

Applicant Leltek, Inc.

K-Number K191235

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KPS 2020-02-12

Biograph Horizon

Applicant Siemens Medical Solution USA, Inc.

K-Number K193178

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LBH 2020-02-11

Cervitec F

Applicant Ivoclar Vivadent, AG

K-Number K191453

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NXC 2020-02-11

ULab Systems Dental Aligner Kit

Applicant Ulab Systems, Inc.

K-Number K192596

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LLZ 2020-02-11

Acteon Imaging Suite

Applicant De Gotzen S.R.L.

K-Number K192165

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DQK 2020-02-11

AcQMap High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K-Number K193013

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PBX 2020-02-11

CAPENERGY - C100, C200, C300, C400, C50

Applicant Capenergy Medical S.L.

K-Number K191202

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EHD 2020-02-11

EzRay Air Portable (Model: VEX-P300)

Applicant VATECH Co., Ltd.

K-Number K200182

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OCC 2020-02-10

cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System

Applicant Roche Molecular Systems, Inc.

K-Number K200065

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IYE 2020-02-10

Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon

Applicant Varian Medical Systems, Inc.

K-Number K192377

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