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

GEI 2017-10-10

InMode RF System

Applicant Inmode MD , Ltd.

K-Number K171593

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DWJ 2017-10-10

3M Bair Hugger Model 675 Total Temperature Management System

Applicant 3M Company

K-Number K171373

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GEX 2017-10-06

MT ONE

Applicant M&T S.R.L.

K-Number K172413

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MHX 2017-10-06

IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable

Applicant Philips Medizin Systeme Boeblingen GmbH

K-Number K171801

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JAK 2017-10-06

Aquilion Prime SP, TSX-303B/1, v8.4

Applicant Toshiba Medical Systems Coroporation

K-Number K172188

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LBI 2017-10-06

Bilicocoon Phototherapy System

Applicant Neomedlight

K-Number K163526

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HJO 2017-10-06

Digital Eye Anterior Camera

Applicant Medimaging Integrated Solution, Inc (Miis)

K-Number K170470

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GWL 2017-10-06

Sienna Ultimate Wireless Amplifier

Applicant Ems Handels Gesellschaft M.B.H.

K-Number K171397

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DZE 2017-10-06

Kisses Mini

Applicant Achimhai Medical Corporation

K-Number K170394

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NBW 2017-10-06

Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System

Applicant Tyson Bioresearch, Inc.

K-Number K170079

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KNT 2017-10-06

Low Profile Non-Balloon Feeding Device

Applicant Applied Medical Technology, Inc.

K-Number K170319

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MQB 2017-10-06

Edge Digital Flat Panel X-ray Detector

Applicant Osko, Inc.

K-Number K172682

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