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

LLZ 2016-01-15

HEALTHMYNE

Applicant Healthmyne, Inc.

K-Number K153289

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GEI 2016-01-15

Bovie Disposable Bipolar Ablator

Applicant Bovie Medical Corporation

K-Number K152777

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HKY 2016-01-15

Falck Medical Multifunction Tonometer, FAT1

Applicant Falck Medical, Inc.

K-Number K151491

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PLA 2016-01-15

Esophageal Cooling Device

Applicant Advanced Cooling Therapy, LLC

K-Number K152450

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MAX 2016-01-15

Spine Wave Gen II Expandable Interbody System

Applicant Spine Wave, Inc.

K-Number K152620

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OUH 2016-01-15

VIVACE Electrosurgical System

Applicant Sung Hwan E&B Co.,Ltd

K-Number K150409

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OWB 2016-01-15

INFX-8000C, V6.20

Applicant Toshibamedical Systems Corporation

K-Number K152697

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MAX 2016-01-14

Spine Innovation Interbody System

Applicant Spine Innovation, LLC

K-Number K153356

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IZQ 2016-01-14

OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System

Applicant Liebel-Flarsheim Company, LLC

K-Number K152361

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HKI 2016-01-14

LipiView II Ocular Surface Interferometer

Applicant Tearscience, Inc.

K-Number K152869

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FRG 2016-01-14

Turbett Surgical Container

Applicant Turbett Surgical, LLC

K-Number K153025

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EIH 2016-01-14

Rainbow Shine

Applicant Genoss

K-Number K151842

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