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

IYN 2016-09-08

SonoSite iViz Ultrasound System

Applicant FUJIFILM Sonosite, Inc.

K-Number K162288

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FOZ 2016-09-08

BioFlo Midline Catheter

Applicant Navilyst Medical, Inc.

K-Number K161866

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DZE 2016-09-08

BBX1, BBX2, BBX1MO, BBX1MC

Applicant Globaldental, Inc.

K-Number K142846

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MQB 2016-09-08

PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector

Applicant Perkinelmer, Inc.

K-Number K161966

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BZD 2016-09-08

Luna CPAP and Auto CPAP System

Applicant 3B Medical, Inc.

K-Number K153387

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KCT 2016-09-07

Signia sterilization tray

Applicant Covidien

K-Number K161347

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FRO 2016-09-07

Procellera

Applicant Vomaris Innovations, Inc.

K-Number K160783

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CFR 2016-09-07

ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II

Applicant Elitechgroup

K-Number K153644

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HGM 2016-09-07

Central Monitoring System

Applicant Guangdong Biolight Meditech Co., Ltd.

K-Number K153580

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FMI 2016-09-07

CareSens Pen Needle, Softip Pen Needle

Applicant Yidobio, Inc.

K-Number K160575

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HRS 2016-09-07

Additive Orthopaedics Bone Wedge System

Applicant Additive Orthopaedics, LLC

K-Number K153207

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GCJ 2016-09-07

Pelican Sling Retractor

Applicant Beacon Surgical, Inc.

K-Number K153542

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