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

FJL 2017-03-24

Veloxion System

Applicant Corinth Medtech, Inc.

K-Number K162979

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NHA 2017-03-24

PREMIUM - SHELTA Prosthetic Components

Applicant Sweden & Martina S.P.A.

K-Number K162028

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GXH 2017-03-24

iovera system

Applicant Myoscience, Inc.

K-Number K161835

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GEX 2017-03-24

LIGHTFUSION LED SYSTEM

Applicant Vitage Led, Ltd.

K-Number K162556

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ODP 2017-03-24

NuVasive CoRoent Small Interbody System

Applicant Nu Vasive, Incorporated

K-Number K163491

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NUC 2017-03-24

LUVENA VAGINAL MOISTURIZER & LUBRICANT

Applicant Laclede, Inc.

K-Number K162235

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JAQ 2017-03-24

Mould Applicator Set

Applicant Varian Medical Systems, Inc.

K-Number K162615

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HRS 2017-03-24

NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System

Applicant Narang Medical USA Corporation

K-Number K163425

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OWP 2017-03-24

VERIFY Assert Self-Contained Biological Indicator

Applicant STERIS Corporation

K-Number K162701

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HQC 2017-03-24

Stellaris Elite Vision Enhancement System

Applicant Bausch+Lomb

K-Number K162342

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EBF 2017-03-24

nuance UNIVERSAL

Applicant Den-Mat Holdings, LLC

K-Number K162967

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OWP 2017-03-24

VERIFY Incubator for Assert Self Contained Biological Indicators

Applicant STERIS Corporation

K-Number K163587

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