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

NKG 2017-05-11

Connector System

Applicant Orthofix, Inc.

K-Number K170647

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OLO 2017-05-11

Mako Partial Knee Application

Applicant Mako Surgical Corp.

K-Number K170584

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FMI 2017-05-11

Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K161950

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MQB 2017-05-11

GMR40

Applicant Neurologica Corporation, A Subsidiary OF

K-Number K171085

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FTL 2017-05-11

GORE SYNECOR Preperitoneal Biomaterial

Applicant W. L. Gore & Associates, Inc.

K-Number K163576

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MQF 2017-05-11

Kitazato IUI Catheter

Applicant Kitazato Corporation

K-Number K162667

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LLZ 2017-05-11

Lung Vision

Applicant Bodyvision Medical , Ltd.

K-Number K163622

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DXN 2017-05-11

Fully Automatic Electronic Blood Pressure Monitor

Applicant Andon Health Co, Ltd.

K-Number K163276

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NKB 2017-05-11

CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems

Applicant Medtronic Sofamor Danek

K-Number K170679

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NUH 2017-05-11

Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203

Applicant Shenzhen Kentro Medical Electronics Co., Ltd.

K-Number K170205

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OLO 2017-05-11

Mako Total Knee Application

Applicant Mako Surgical Corp.

K-Number K170581

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LYY 2017-05-11

UniTex Non-Sterile, Powder-Free, Latex Examination Glove

Applicant Ug Global Resources Sdn. Bhd.

K-Number K161961

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