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

QEY 2016-10-31

Squirt Fluid Delivery System

Applicant Merit Medical Systems, Inc.

K-Number K162777

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DWM 2016-10-31

Pleurx Pleural Catheter System

Applicant Care Fusion

K-Number K160450

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EMA 2016-10-31

Glass Ionomer Cement (Luting)

Applicant Shandong Huge Dental Material Corporation

K-Number K161851

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GXY 2016-10-30

FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W

Applicant Medico Electrodes International , Ltd.

K-Number K161282

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GEX 2016-10-28

Cutera enlighten III Laser System

Applicant Cutera, Inc.

K-Number K160488

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HGX 2016-10-28

Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail

Applicant Medela, Inc.

K-Number K161725

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MAX 2016-10-28

SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene

Applicant SeaSpine Orthopedics Corporation

K-Number K162715

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JXG 2016-10-28

Codman EDS3 CSF External Drainage System

Applicant Codman & Shurtleff, Inc.

K-Number K162437

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OAS 2016-10-28

PaX-i3D Green Premium (Model: PCT-90LH)

Applicant VATECH Co., Ltd.

K-Number K160882

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MQB 2016-10-28

ClearVision ExamVue Flat Panel Detector

Applicant Jpi Healthcare, Inc.

K-Number K160143

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KRO 2016-10-28

ELEOS Limb Salvage System

Applicant Onkos Surgical, Inc.

K-Number K161520

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BSP 2016-10-28

Tuohy NRFit

Applicant PAJUNK GmbH Medizintechnologie

K-Number K160297

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