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

LLZ 2018-12-20

3DIEMME RealGUIDE

Applicant 3Diemme , Ltd.

K-Number K173041

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PAM 2018-12-20

ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel

Applicant Genmark Diagnostics, Incorporated

K-Number K181663

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DQY 2018-12-20

ASAHI Corsair Pro XS

Applicant Asahi Intecc Co., Ltd.

K-Number K182420

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JWY 2018-12-20

MTS Levofloxacin 0.002 - 32 µg/mL

Applicant Liofilchem s.r.l.

K-Number K183115

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QEF 2018-12-20

SEM Scanner (Model 200)

Applicant Bruin Biometrics, LLC

K-Number DEN170021

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NUC 2018-12-20

Natureplex Warm Touch Warming Jelly

Applicant Natureplex, LLC

K-Number K180828

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LRC 2018-12-20

Sinusway Dilation System

Applicant 3nt Medical , Ltd.

K-Number K181838

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DXT 2018-12-20

DyeVert NG Contrast Reduction System, DyeVert PLUS EZ Contrast Reduction System, DyeTect Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert PLUS EZ Contrast Reduction System

Applicant Osprey Medical, Inc.

K-Number K183267

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IYN 2018-12-20

Color Doppler Ultrasound System; Model: mEye1 and mEye2

Applicant Shenzhen Well.D Medical Electronics Co., Ltd.

K-Number K182165

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BTT 2018-12-20

AirSpiral Heated Breathing Tube

Applicant Fisher & Paykel Healthcare

K-Number K162553

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CAW 2018-12-20

O2 Concepts Oxlife Independence Model 301-0001

Applicant O2 Concepts, LLC

K-Number K182454

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OZZ 2018-12-19

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

Applicant Diasorin Molecular, LLC

K-Number K183223

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