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

OLO 2018-06-29

NuVasive Pulse System

Applicant Nu Vasive, Incorporated

K-Number K180038

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NHV 2018-06-29

Ecolab POU Water Filter

Applicant Ecolab, Inc.

K-Number K173164

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KGE 2018-06-29

Ensizor Monopolar Endoscopic Scissors

Applicant Slater Endoscopy, LLC

K-Number K180134

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IYE 2018-06-29

Proton Positioing and Immobilization Devices

Applicant Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap

K-Number K180021

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JOW 2018-06-29

Venera 508 Deep Vein Thrombosis (DVT) Prevention System

Applicant Suzhou Minhua Medical Apparatus Supplies Co., Ltd.

K-Number K180389

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LPL 2018-06-29

Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia

Applicant Largan Medical Co., Ltd.

K-Number K181232

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FET 2018-06-28

LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD

Applicant Richard Wolf Medical Instruments Corporation

K-Number K180583

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GXY 2018-06-28

ZMI Self-Adhesive Electrodes

Applicant Zmi Electronics , Ltd.

K-Number K180865

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IYE 2018-06-28

Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator

Applicant Varian Medical Systems, Inc.

K-Number K181404

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DZE 2018-06-28

KJ ZIRCONIA Implant System

Applicant Kj Meditech Co., Ltd.

K-Number K173116

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PZX 2018-06-28

ArtiClip LAA Exclusion System

Applicant AtriCure, Inc.

K-Number K181474

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GEX 2018-06-28

Beacon Advanced CO2 Laser System

Applicant Omniguide, Inc.

K-Number K180993

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