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

EIH 2018-03-08

DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid

Applicant Dmax Co., Ltd.

K-Number K173769

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MSQ 2018-03-08

BreathID Hp System

Applicant Exalenz Bioscience , Ltd.

K-Number K173772

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DXQ 2018-03-08

Accutension Smartphone Auscultatory Blood

Applicant Shanghai Hulu Devices Co., Ltd.

K-Number K180335

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IYN 2018-03-08

HS70A Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K173713

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MQK 2018-03-08

ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)

Applicant Dxnow, Inc.

K-Number K173075

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GEX 2018-03-08

SIROLaser Blue

Applicant Dentsply Sirona

K-Number K180044

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LLZ 2018-03-08

icobrain

Applicant Icometrix

K-Number K180326

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NKB 2018-03-08

CD HORIZON Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K173249

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ELC 2018-03-08

AW-100

Applicant Micron Corporation

K-Number K171150

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EBF 2018-03-08

NMF004A

Applicant GC America, Inc.

K-Number K173500

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NSI 2018-03-08

PillCam Patency System

Applicant Given Imaging , Ltd.

K-Number K180171

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QEW 2018-03-08

Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister

Applicant Penumbra, Inc.

K-Number K180105

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