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

CGZ 2018-10-30

VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides

Applicant Ortho-Clinical Diagnostics, Inc.

K-Number K182072

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JOY 2018-10-30

Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device

Applicant Sysmex America, Inc.

K-Number K182062

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DRE 2018-10-29

MC3 Vascular Access Kit 21030

Applicant Mc3 Incorporated

K-Number K182914

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GKZ 2018-10-29

HemoScreen Hematology Analyzer

Applicant Pixcell Medical Technologies, Ltd.

K-Number K180020

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FTC 2018-10-29

ClearLink Controlled Phototherapy Equipment

Applicant Daavlin Distributing Company

K-Number K182215

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PGI 2018-10-29

HSV 1 & 2 ELITe MGB Kit; ELITe InGenius

Applicant Elitechgroup

K-Number K180559

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FLL 2018-10-29

Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer

Applicant Joytech Healthcare Co. , Ltd.

K-Number K181239

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NLH 2018-10-27

Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter

Applicant Innovative Health, LLC

K-Number K181458

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NKB 2018-10-27

ORTHROS Posterior Stabilization System; ORTHROS MIS Posterior Stabilization System

Applicant Camber Spine Technologies, LLC

K-Number K180980

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BZH 2018-10-26

Peak.me

Applicant Breathe Me, Ltd.

K-Number K180487

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LKF 2018-10-26

Cook Silicone Balloon HSG Catheter

Applicant Cook Incorporated

K-Number K180291

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NXC 2018-10-26

Invisalign System with Mandibular Advancement Feature

Applicant Align Technology, Inc.

K-Number K181739

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