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

POS 2019-05-11

SPEAC System

Applicant Brain Sentinel, Inc.

K-Number K182180

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IRP 2019-05-10

Therm-X

Applicant Zenith Technical Innovations

K-Number K190854

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IYN 2019-05-10

ExactVu High Resolution Micro-Ultrasound System

Applicant Exact Imaging, Inc.

K-Number K190995

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IYN 2019-05-10

6400 Ultrasound System (MyLabX6, MyLabX7)

Applicant Esaote, S.p.A.

K-Number K190989

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LZA 2019-05-10

Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue)

Applicant Zibo Yahao Supplies Co., Ltd.

K-Number K182612

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LEJ 2019-05-10

Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound

Applicant Jk-Holding GmbH

K-Number K190173

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OWN 2019-05-10

L10 LED Light Source with AIM, L11 LED Light Source with AIM

Applicant Stryker

K-Number K191046

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HIH 2019-05-10

Hysteroscope System

Applicant Shanghai AnQing Medical Instrument Co., Ltd.

K-Number K181545

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PMY 2019-05-10

GenePOC Carba

Applicant Genepoc, Inc.

K-Number K190275

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ORC 2019-05-10

SteriStay

Applicant Toul Meditech AB

K-Number K190027

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JWH 2019-05-10

Vanguard Complete Knee System

Applicant Zimmer, Inc.

K-Number K183583

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MQE 2019-05-10

Wallace Dual Lumen Oocyte Recovery System

Applicant CooperSurgical, Inc.

K-Number K182959

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