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

OPT 2020-07-10

Infrascanner

Applicant Infrascan, Inc.

K-Number K200203

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LFL 2020-07-10

Sonicision Cordless Ultrasonic Dissector

Applicant Covidien, LLC

K-Number K200427

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OLO 2020-07-10

ExcelsiusGPS Cranial 1.0 Module

Applicant Globus Medical, Inc.

K-Number K200047

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LLZ 2020-07-10

AI-Rad Companion Engine

Applicant Siemens Medical Solutions USA, Inc.

K-Number K193294

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JAQ 2020-07-10

ASSISTO Universal Applicator Clamping Device

Applicant Geomed Medizin-Technik GmbH & Co. KG

K-Number K201279

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LNH 2020-07-10

Resoundant Acoustic Driver System

Applicant Resoundant, Inc.

K-Number K201389

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KPR 2020-07-10

DigitalDiagnost C50

Applicant Philips Healthcare (Suzhou) Co., Lit.

K-Number K201725

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IYN 2020-07-10

X-Cube 70

Applicant Alpinion Medical Systems Co., Ltd.

K-Number K200450

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MUJ 2020-07-10

Eclipse Treatment Planning System v16.1

Applicant Varian Medical Systems, Inc.

K-Number K201607

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DXN 2020-07-10

Automatic Upper Arm Blood Pressure Monitor

Applicant Dongguan E-Test Technology Co., Ltd.

K-Number K193624

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HSN 2020-07-10

Paragon 28 APEX 3D Total Ankle Replacement System

Applicant Paragon 28, Inc.

K-Number K192994

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JOW 2020-07-10

B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System

Applicant B&J Manufacturing , Ltd.

K-Number K200568

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