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

MMK 2018-05-11

HealthBeacon HB2 Sharps Bin

Applicant Healthbeacon, Ltd.

K-Number K172719

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EWO 2018-05-11

GSI Corti

Applicant Grason-Stadler, Inc.

K-Number K180287

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MHX 2018-05-11

µCor Heart Failure and Arrhythmia Management System

Applicant Zoll Manufacturing Corporation

K-Number K172510

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BTM 2018-05-11

Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer

Applicant Foremount Enterprise Co., Ltd.

K-Number K170663

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FLL 2018-05-11

Infrared Body Thermometer

Applicant Hetaida Technology Co., Ltd.

K-Number K180385

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MQG 2018-05-11

EmbryoScope+

Applicant Vitrolife A/S

K-Number K173264

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JAK 2018-05-11

LineUp

Applicant Curvebeam, LLC

K-Number K180727

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FRN 2018-05-11

Spectrum IQ Infusion System, Dose IQ Safety Software

Applicant Baxter Healthcare Corporation

K-Number K173084

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IYN 2018-05-11

HS40 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K180409

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NHN 2018-05-11

Collagentex Rx-6

Applicant Tanses Technologies, Inc.

K-Number K180585

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DQA 2018-05-11

Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor

Applicant Nonin Medical, Inc.

K-Number K172625

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KGN 2018-05-11

Cytal Wound Particulate

Applicant Acell, Inc.

K-Number K180776

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