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

NJM 2019-11-04

Mei Ceramic Bracket

Applicant Orthosun Co., Ltd.

K-Number K190608

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OCL 2019-11-04

Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen

Applicant AtriCure, Inc.

K-Number K192125

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KPR 2019-11-04

DRX-Evolution/Plus with Dual Energy

Applicant Carestream Health, Inc.

K-Number K190330

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PCH 2019-11-04

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

Applicant Luminex Molecular Diagnostics, Inc.

K-Number K191160

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HTN 2019-11-04

LARS AC Band Device

Applicant Corin USA

K-Number K190143

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MQV 2019-11-03

NuVasive AttraX Putty

Applicant Nu Vasive, Incorporated

K-Number K191974

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MAI 2019-11-02

Parcus Knotless AP Suture Anchors

Applicant Parcus Medical, LLC

K-Number K192824

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EMA 2019-11-02

Allcem, Allcem Core

Applicant Dentscare Ltda

K-Number K183465

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GEX 2019-11-01

BC-5

Applicant Reveallux, Corp

K-Number K191693

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NUH 2019-11-01

Combo Electrotherapy Device

Applicant Shenzhen Roundwhale Technology Co. , Ltd.

K-Number K192087

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EBI 2019-11-01

NextDent Denture 3D+

Applicant Vertex-Dental B.V.

K-Number K191497

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MUD 2019-11-01

MIMOSA Imager

Applicant Mimosa Diagnostics, Inc.

K-Number K190334

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