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

DRE 2016-07-22

Sheath Introducer

Applicant Bioteque Corp.

K-Number K150932

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JAK 2016-07-22

Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4

Applicant Toshibamedical Systems Corporation

K-Number K161009

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DSI 2016-07-22

Braemar Telemetry Patch System

Applicant Braemar Manufacturing, LLC

K-Number K153473

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LYR 2016-07-22

LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set

Applicant DiaSorin, Inc.

K-Number K161139

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DZE 2016-07-21

ET III Bio-SA Fixture System

Applicant Hiossen, Inc.

K-Number K151626

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NKB 2016-07-21

EVEREST Spinal System

Applicant K2m, Incorporated

K-Number K161369

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OVD 2016-07-21

MectaLIF Anterior Stand-Alone

Applicant Medacta International

K-Number K160605

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DYB 2016-07-21

GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle

Applicant Creganna Medical Aslo Business AS Cregganna Tactx Medical

K-Number K152913

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MAX 2016-07-21

Genesys Spine Apache® Lateral Lumbar Interbody Fusion System

Applicant Genesys Spine

K-Number K161404

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EBF 2016-07-21

SHOFU Enamel Conditioner

Applicant Shofu Dental Corporation

K-Number K160086

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PKT 2016-07-21

SculpSure

Applicant Cynosure, Inc.

K-Number K160470

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GEI 2016-07-21

INTRAcel Premium Fractional RF Micro Needle (FRM) System

Applicant Jeisys Medical, Inc.

K-Number K153727

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