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

LQZ 2021-07-20

The Slide

Applicant Biotex, Inc.

K-Number K203712

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PBX 2021-07-20

RF Thermal System

Applicant Luvo Medical Technologies, Inc.

K-Number K210129

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DSH 2021-07-20

LifeLens Wireless ECG Monitor

Applicant LifeLens Technologies, Inc.

K-Number K203168

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HSB 2021-07-19

Elos® Intramedullary Nailing System

Applicant Intrauma S.P.A

K-Number K201147

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PGW 2021-07-19

Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D

Applicant Fiagon GmbH

K-Number K211291

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SBF 2021-07-19

xvision Spine system (XVS)

Applicant Augmedics, Ltd.

K-Number K211188

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LZO 2021-07-19

POLARSTEM Calcar Reamer Guide

Applicant Smith & Nephew, Inc.

K-Number K211548

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NKB 2021-07-19

ENNOVATE Spinal System

Applicant Aesculap Implant Systems, LLC

K-Number K210963

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PBX 2021-07-19

Evolve System with the T3 Applicator

Applicant InMode , Ltd.

K-Number K210877

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DXF 2021-07-19

Z-6 Atrioseptostomy Catheter

Applicant NuMED, Inc.

K-Number K211910

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LYZ 2021-07-17

Powder Free Vinyl Patient Examination Gloves

Applicant Shijiazhuang Hongjun Plastic Manufacture Co., Ltd.

K-Number K211177

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LYZ 2021-07-17

Vinyl Patient Examination Gloves

Applicant Jiangxi Shengda Medical Technology Co., Ltd.

K-Number K211239

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