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

MYN 2021-07-20

Chest-CAD

Applicant Imagen Technologies, Inc.

K-Number K210666

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OAP 2021-07-20

Grivamax Family of Lasers, Models 272 and 148

Applicant Leana Orders, Inc.

K-Number K211192

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EBF 2021-07-20

TKO Composite Bite Turbo Gel

Applicant Reliance Orthodontic Products, Inc.

K-Number K210349

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QME 2021-07-20

Vital Signs

Applicant Oxehealth Limited

K-Number K211906

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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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