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

GZF 2016-03-11

StimQ Peripheral Nerve Stimulator (PNS) System

Applicant Stimq, LLC

K-Number K152178

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NHA 2016-03-10

Thommen Milling Abutment for CAD/CAM

Applicant Thommen Medical AG

K-Number K151984

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MUH 2016-03-10

ReadeR, VieweR, QuickScan PSP

Applicant Trident S.R.L

K-Number K160386

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DCK 2016-03-10

QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument

Applicant Orion Diagnostica, OY

K-Number K142993

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HSN 2016-03-10

Exactech Vantage Total Ankle System

Applicant Exactech, Inc.

K-Number K152217

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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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