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

IYN 2016-03-25

LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K160277

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PAM 2016-03-25

Great Basin Staph ID/R Blood Culture Panel

Applicant Great Basin Scientific, Inc.

K-Number K152470

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JWH 2016-03-25

iTotal Cruciate Retaining (CR) Knee Replacement System

Applicant Conformis, Inc.

K-Number K153721

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MAX 2016-03-25

SurgTech Interbody System

Applicant Surgtech, Inc.

K-Number K152200

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FZP 2016-03-25

Vas-Q-Clip

Applicant Nanova Biomaterials, Inc.

K-Number K151943

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EIH 2016-03-25

MSCB-001

Applicant GC America, Inc.

K-Number K152274

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NGZ 2016-03-25

VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)

Applicant bioMerieux, Inc.

K-Number K151923

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BWF 2016-03-25

VibraPEP

Applicant Medica Holdings, LLC

K-Number K153441

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JDI 2016-03-25

Corin TaperFit Hip Stem

Applicant Corin U.S.A. Limited

K-Number K153725

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MEG 2016-03-25

U&U Insulin Syringe with/without Safety Retractable Device

Applicant U&U Medical Technology Co, Ltd.

K-Number K152808

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HRS 2016-03-25

Align Anterior Ankle Fusion Plate

Applicant Extremity Medical, LLC

K-Number K160191

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GEH 2016-03-25

truFreeze System

Applicant Csa Medial, Inc.

K-Number K160273

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