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

DXN 2017-07-07

Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series

Applicant Grandway Technology (Shenzhen) Limited

K-Number K163648

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LOX 2017-07-07

RX NC Takeru PTCA Balloon Dilatation Catheter

Applicant KANEKA Corporation

K-Number K170941

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QPC 2017-07-07

Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns

Applicant Bam Corporation Limited

K-Number K160337

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OOK 2017-07-07

ZELTIQ CoolSculpting System

Applicant Zeltiq Aesthetics, Inc.

K-Number K171069

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MHX 2017-07-07

M3290B Philips IntelliVue Information Center iX

Applicant Philips Medical Systems

K-Number K163584

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LJH 2017-07-07

Karl Storz UROMAT E.A.S.I.

Applicant Karl Storz Endoscopy America, Inc.

K-Number K162992

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MQB 2017-07-07

Models 3543A, 4343A, 2929A and A843B

Applicant Shanghai PZ Medical Technolgoy Co., Ltd.

K-Number K170480

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MQB 2017-07-07

SkyPlate Detector for Philips Radiography/Fluoroscopy Systems

Applicant Philips Medical Systems Dmc GmbH

K-Number K171461

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ILY 2017-07-07

AXON IR Heat Lamp

Applicant Crystal Medtech, LLC

K-Number K171087

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DXT 2017-07-07

Smart Syringe

Applicant Osprey Medical, Inc.

K-Number K171698

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KPI 2017-07-07

Everyway Incontinence Stimulation System

Applicant Everyway Medical Instrument Co., Ltd.

K-Number K161349

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FBK 2017-07-07

Interject Injection Therapy Needle Catheter

Applicant Boston Scientific Corporation

K-Number K171454

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