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

JAK 2019-07-26

Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

Applicant Ge Medical Systems, LLC

K-Number K191777

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OTK 2019-07-26

The ZIP Accessory Shuttle for PleuraFlow System

Applicant Clearflow, Inc.

K-Number K191733

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JFY 2019-07-26

ACR LAB Urine Analysis Test System

Applicant Healthy.Io, Ltd.

K-Number K182384

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FLE 2019-07-26

STATCLAVE G4 Chamber Autoclave

Applicant Scican , Ltd.

K-Number K190062

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PEM 2019-07-26

ScanX Barrier Envelopes

Applicant Air Techniques, Inc.

K-Number K190949

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QHQ 2019-07-26

Arthrex Eclipse Shoulder Prosthesis System

Applicant Arthrex, Inc.

K-Number K183194

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MOF 2019-07-26

ASAHI Neurovascular Guide Wire CHIKAI X 014 soft

Applicant Asahi Intecc Co., Ltd.

K-Number K191714

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OAP 2019-07-26

Hair Growth System

Applicant Xuzhou Kernel Medical Equipment Co., Ltd.

K-Number K190685

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CBK 2019-07-26

Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented

Applicant Sleepnet Corporation

K-Number K190533

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MQL 2019-07-26

RapidVit™ Oocyte, RapidWarm™ Oocyte

Applicant Vitrolife Sweden AB

K-Number K183486

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FLL 2019-07-26

Infrared Ear/Forehead Thermometer

Applicant Joytech Healthcare Co. , Ltd.

K-Number K190873

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JAK 2019-07-26

AI-Rad Companion (Pulmonary)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K183271

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