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

DPS 2018-01-26

MiCor A100 Wearable ECG Recorder

Applicant Mitac International Corp.

K-Number K162665

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NHA 2018-01-26

Panthera Dental Milled Bars

Applicant Panthera Dental, Inc.

K-Number K173466

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OCC 2018-01-26

Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2

Applicant Alere Scarborough, Inc.

K-Number K173932

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OLW 2018-01-26

SedLine Sedation Monitor

Applicant Masimo Corporation

K-Number K172890

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LYY 2018-01-26

SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)

Applicant Sanrea Healthcare Products Pvt, Ltd.

K-Number K171367

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POS 2018-01-26

Embrace

Applicant Empatica S.r.l.

K-Number K172935

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LNH 2018-01-26

Vantage Galan 3T, V4.6

Applicant Toshibamedical Systems Corporation

K-Number K173382

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OAP 2018-01-26

illumiflow 148 Laser Cap

Applicant Eglobal, LLC

K-Number K173843

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DXJ 2018-01-26

Essence 55S Large Monitor System

Applicant Shenyang Torch-Bigtide Digital Technology Co., Ltd.

K-Number K172969

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QEW 2018-01-26

V2K Rinspiration System

Applicant V2k Medical, Inc.

K-Number K172716

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KPR 2018-01-26

uDR 780i

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K173953

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GEI 2018-01-26

Stryker 90-S Max SERFAS Energy Probe

Applicant Stryker

K-Number K171391

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