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

MQV 2016-12-02

Cerasorb Ortho Foam

Applicant Curasan AG

K-Number K160566

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LLZ 2016-12-02

MEDSYNAPSE Zero Footprint Viewer

Applicant Medsynaptic Private, Ltd.

K-Number K163158

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MNH 2016-12-02

Reliance Spinal Screw System

Applicant Reliance Medical Systems, LLC

K-Number K162066

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IYO 2016-12-02

ExactVu High Resolution Micro-Ultrasound System

Applicant Exact Imaging

K-Number K162972

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MQB 2016-12-02

EVS 3643, EVS 3643G

Applicant DRTECH Corporation

K-Number K162552

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KGI 2016-12-02

GE Lunar DXA Bone Densitometers with enCORE version 17

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K-Number K161682

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DWJ 2016-12-02

Altrix Precision Temperature Management System

Applicant Stryker Medical

K-Number K152266

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ONZ 2016-12-02

TAV System

Applicant New Aera, Inc.

K-Number K152664

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PDU 2016-12-02

Pioneer Plus Catheter

Applicant Philips Volcano

K-Number K162418

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GEX 2016-12-01

Litho

Applicant Quanta System Spa

K-Number K163009

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JWH 2016-12-01

LOSPA Modular Knee System

Applicant Corentec Co., Ltd.

K-Number K160157

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OMP 2016-12-01

Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply

Applicant Medela AG

K-Number K161128

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