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

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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HRS 2016-01-14

ARIX Wrist System

Applicant Jeil Medical Corporation

K-Number K151468

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PHX 2016-01-14

Aequalis Fx2

Applicant Tornier S.A.S.

K-Number K152966

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LKN 2016-01-14

Spectra Optia Apheresis System

Applicant Terumobct, Inc.

K-Number K153601

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PGD 2016-01-14

PillCam COLON 2 Capsule Endoscopy System

Applicant Given Imaging , Ltd.

K-Number K153466

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OQY 2016-01-14

ebb Complete Tamponade System

Applicant Clinical Innovations, LLC

K-Number K153591

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MPN 2016-01-14

GluStitch Twist Tissue Adhesive

Applicant Glustitch, Inc.

K-Number K150032

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CFR 2016-01-14

Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method

Applicant Diatron U.S., Inc.

K-Number K151487

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