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

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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EBW 2017-05-11

A-dec NLZ Electric Motor System

Applicant Nakanishi, Inc.

K-Number K163131

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LLZ 2017-05-11

SurgiCase Viewer

Applicant Materialise NV

K-Number K170419

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DPS 2017-05-11

Anybattery C2 Rechargeable Battery

Applicant Anybattery, Inc.

K-Number K160667

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LLZ 2017-05-11

Longitudinal Brain Imaging (LoBI) application

Applicant Philips Medical Systems Nederland B.V.

K-Number K163250

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MQX 2017-05-11

AIK Sterile Acupuncture Needles for Single Use

Applicant Changchun Aik Medical Devices Co., Ltd.

K-Number K162566

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