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

OTK 2016-01-20

PleuraFlow System

Applicant Clearflow, Inc.

K-Number K153681

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KCT 2016-01-20

Medtronic Transportation/Sterilization Cassettes

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K152241

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LPL 2016-01-20

DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal

Applicant Alcon Laboratories, Inc.

K-Number K153642

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BZE 2016-01-20

AirLife Infant Single Limb Heated Wire Circuit

Applicant Carefusion, Inc.

K-Number K151959

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IYN 2016-01-20

SonoSite Edge II Ultrasound System

Applicant FUJIFILM Sonosite, Inc.

K-Number K153626

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LPL 2016-01-20

Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives

Applicant Alcon Laboratories, Inc.

K-Number K153643

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ONF 2016-01-20

Venus Versa System

Applicant Venus Concept , Ltd.

K-Number K152790

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FWP 2016-01-20

SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant

Applicant Poriferous, LLC

K-Number K152463

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KLW 2016-01-20

Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System

Applicant Neurotherapies Reset GmbH

K-Number K151558

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MAX 2016-01-20

AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer

Applicant Stryker Corporation

K-Number K151726

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JAK 2016-01-20

Stroke VCAR

Applicant GE Medical Systems SCS

K-Number K152584

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MAV 2016-01-20

basixTOUCH40 Inflation Syringe

Applicant Merit Medical Systems, Inc.

K-Number K153672

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