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

HEW 2020-05-21

Advincula Delineator Uterine Manipulator

Applicant CooperSurgical, Inc.

K-Number K201086

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GEI 2020-05-21

gi-4000 Electrosurgical Generator

Applicant United States Endoscopy Group, Inc.

K-Number K192265

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KNS 2020-05-21

Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)

Applicant Hangzhou AGS MedTech Co., Ltd.

K-Number K192342

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JOJ 2020-05-21

Getinge Assured MI Steam Migrating Integrator

Applicant Steritec Products Mfg Co, Inc.

K-Number K200252

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FFX 2020-05-21

IntraMarX 3D Radiopaque Marker

Applicant Anx Robotica Corp

K-Number K201106

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IYN 2020-05-21

Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System

Applicant Edan Instruments, Inc.

K-Number K192879

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MAX 2020-05-21

NEXXT MATRIXX System

Applicant Nexxt Spine, LLC

K-Number K200969

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KWQ 2020-05-21

NuVasive Thoracolumbar Plates

Applicant Nu Vasive, Incorporated

K-Number K200956

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GEX 2020-05-21

Photodynamic Therapy (PDT) Equipment

Applicant Shangdong Huamei Technology Co., Ltd.

K-Number K200751

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PLV 2020-05-21

X-Guide® Surgical Navigation System

Applicant X-Nav Technologies, LLC

K-Number K200662

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LLZ 2020-05-21

CariCloud

Applicant Caristo Diagnostics

K-Number K200274

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ORZ 2020-05-21

Systane iLux2

Applicant Tear Film Innovations, Inc.

K-Number K200400

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