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

IYE 2018-01-17

ARIA Radiation Therapy Management

Applicant Varian Medical Systems, Inc.

K-Number K173838

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BTR 2018-01-17

Endotracheal tube; Reinforced Endotracheal tube

Applicant Zhanjiang Star Enterprise Co., Ltd.

K-Number K170234

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FMI 2018-01-17

NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)

Applicant Novo Nordisk, Inc.

K-Number K173479

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LLZ 2018-01-16

Navigo Workstation Version 2.0

Applicant UC-CARE , Ltd.

K-Number K173054

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LLZ 2018-01-16

CS Imaging

Applicant Trophy

K-Number K173622

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IPL 2018-01-16

Quickie(r) Q700-UP M

Applicant Sunrise Medical (Us), LLC

K-Number K172384

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MAI 2018-01-16

Arthrex PushLock

Applicant Arthrex, Inc.

K-Number K173240

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KLE 2018-01-16

Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel

Applicant Nanova Biomaterials, Inc.

K-Number K172977

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OLO 2018-01-16

K2M Navigation Instruments

Applicant K2m

K-Number K171556

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HSB 2018-01-16

Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt

Applicant Truemed Group, LLC

K-Number K172189

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PNZ 2018-01-16

ACCLARENT AERA Eustachian Tube Balloon Dilation System

Applicant Acclarent, Inc.

K-Number K171761

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EBI 2018-01-16

Yamahachi Pink CAD/CAM Disk

Applicant YAMAHACHI DENTAL MFG., Co.

K-Number K172683

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