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

NTE 2016-03-10

ENROUTE Transcarotid Neuroprotection System

Applicant Silk Road Medical, Inc.

K-Number K153485

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HSB 2016-03-10

Sonoma Fibula Repair System

Applicant Sonoma Orthopedics Products, Inc.

K-Number K160069

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MBH 2016-03-10

Optetrak One Logic Femoral Components

Applicant Exactech, Inc.

K-Number K153776

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IYN 2016-03-10

Vivid T8

Applicant Ge Medical Systems Ultrasound and Primary Care Diagnotics, L

K-Number K160078

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PGW 2016-03-10

GuideWire

Applicant Fiagon GmbH

K-Number K160369

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OWQ 2016-03-10

Reprocessed Diagnostic Ultrasound Catheter

Applicant Innovative Health, LLC

K-Number K153090

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BZQ 2016-03-10

Thora-3Di, Model T-01

Applicant Pneumacare Limited

K-Number K151940

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LZO 2016-03-10

OMNI Skirted Heads

Applicant Omni Life Science, Inc.

K-Number K152919

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CCK 2016-03-10

Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines

Applicant Salter Labs

K-Number K151421

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GWO 2016-03-10

PEEK Customized Cranial Implant

Applicant Stryker

K-Number K153248

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LZA 2016-03-10

Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color

Applicant Xingda Medical Products Co., Ltd.

K-Number K152720

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KRA 2016-03-09

MMS Guide Catheter

Applicant Micro Medical Solutions, Inc.

K-Number K152625

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