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

LLZ 2016-01-20

Stereo 3D option for Vision Applications

Applicant GE Medical Systems SCS

K-Number K152352

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MXK 2016-01-20

Pentacam AXL

Applicant Oculus Optikgerate GmbH

K-Number K152311

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KDJ 2016-01-20

Firefly Peritoneal Dialysis Connector Disinfection System

Applicant Puracath Medical, Inc.

K-Number K151620

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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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