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

BWF 2016-05-27

O-PEP

Applicant Pari Respiratory Equipment, Inc.

K-Number K150044

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OYJ 2016-05-26

Oragene Dx

Applicant DNA Genotek, Inc.

K-Number K152556

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GCJ 2016-05-26

AdTec

Applicant Aesculap, Inc.

K-Number K160393

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OYJ 2016-05-26

ORAcollect.Dx

Applicant DNA Genotek, Inc.

K-Number K152464

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ODW 2016-05-26

eSensor Warfarin Sensitivity Saliva Test

Applicant Genmark Diagnostics, Incorporated

K-Number K152612

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HRS 2016-05-26

AxSOS 3Ti

Applicant Stryker GmbH

K-Number K153379

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LPL 2016-05-26

Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016

Applicant Visco Vision, Inc.

K-Number K160344

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NKB 2016-05-26

Threshold Pedicular Fixation System, Palisade Pedicular Fixation System

Applicant Spineology, Inc.

K-Number K160980

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BWK 2016-05-26

Stivax

Applicant Biegler GmbH

K-Number K152571

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MXD 2016-05-26

Reveal LINQ

Applicant Medtronic, Inc.

K-Number K160809

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OLO 2016-05-26

Stealth-Midas System

Applicant Medtronic Powered Surgical Solutions

K-Number K160713

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HJO 2016-05-26

Z5 Slit lamp microscope, Z2 Slit lamp microscope

Applicant Takagi Seiko Co., Ltd.

K-Number K152535

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