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

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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QJH 2020-02-10

Surfacer Inside-Out Access Catheter System

Applicant Bluegrass Vascular Technologies, Inc.

K-Number DEN190038

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NHA 2020-02-10

Elos Accurate Hybrid Base

Applicant Elos Medtech Pinol A/S

K-Number K191919

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HWC 2020-02-10

Arthrex Mini Comprehensive Fixation System - 1.0mm Screws

Applicant Arthrex, Inc.

K-Number K193156

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NDC 2020-02-10

InPen System

Applicant Companion Medical, Inc.

K-Number K192841

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NXC 2020-02-10

Argen Clear Aligner, Argen Clear Aligner Premium

Applicant Argen Corporation

K-Number K192846

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