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

DZE 2017-12-01

S.I.N. Implant System

Applicant S.I.N. – Sistema DE Implante Nacional S.A.

K-Number K170392

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GEX 2017-12-01

LightWalker Laser System Family

Applicant Fotona D.O.O.

K-Number K172819

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MAX 2017-12-01

Altus Spine Interbody Fusion System

Applicant Altus Partners, LLC

K-Number K170553

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GEX 2017-12-01

CuRAS Nd:YAG Laser

Applicant Ilooda Co,., Ltd.

K-Number K173038

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DZE 2017-12-01

IR Type Implant System

Applicant Biotem Co., Ltd.

K-Number K171185

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IYE 2017-12-01

EZFluence

Applicant Radformation, Inc.

K-Number K171352

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GXY 2017-12-01

MR Conditional Cup Electrode, MR Conditional Webb Electrode

Applicant Rhythmlink International, LLC

K-Number K172503

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LTT 2017-12-01

MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)

Applicant Beckman Coulter, Inc.

K-Number K172255

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IYO 2017-12-01

DUS-6000 Digital Ultrasonic Diagnostic Imaging System

Applicant Advanced Instrumentations, Inc.

K-Number K172931

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HRS 2017-12-01

ARIX Humerus System

Applicant Jeil Medical Corporation

K-Number K172008

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IYN 2017-12-01

P10 Series Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K173058

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QEZ 2017-12-01

Octane aspiration system

Applicant Vascular Solutions, Inc.

K-Number K173266

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