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

CBI 2018-11-02

Sheridan Endobronchial Tubes

Applicant Teleflex Medical

K-Number K180253

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IYN 2018-11-02

Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System

Applicant Canon Medical Systems Corporation

K-Number K182427

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NQQ 2018-11-02

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System

Applicant Ninepoint Medical, Inc.

K-Number K182616

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JWY 2018-11-02

MTS Eravacycline 0.002 - 32 µg/mL

Applicant Liofilchem s.r.l.

K-Number K182557

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MAX 2018-11-02

Spinal Elements Ti-Bond coated devices

Applicant Spinal Elements, Inc.

K-Number K181837

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MQR 2018-11-02

HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)

Applicant M.I.Tech Co., Ltd.

K-Number K180180

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MQV 2018-11-02

PRODENSE Bone Graft Substitute

Applicant Wrightmedicaltechnologyinc

K-Number K182823

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PND 2018-11-02

Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter

Applicant Vygon USA

K-Number K181208

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DXN 2018-11-02

Wrist Blood Pressure Monitor Model BP6100

Applicant Omron Healthcare, Inc.

K-Number K182127

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LKN 2018-11-01

Spectra Optia Apheresis System

Applicant Terumobct, Inc.

K-Number K181049

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DZE 2018-11-01

Implantswiss Dental Implant System, Implantswiss Dental Abutment System

Applicant Novodent SA

K-Number K181266

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NBW 2018-11-01

GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System

Applicant I-Sens, Inc.

K-Number K181273

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