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

NBY 2017-07-31

WEGO-PTFE

Applicant Foosin Medical Supplies Inc., Ltd.

K-Number K170842

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GEX 2017-07-31

Litho 60

Applicant Quanta System Spa

K-Number K172025

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IYO 2017-07-31

Scanmate Flex

Applicant Dgh Technology, Inc.

K-Number K171301

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DXN 2017-07-31

Electronic Blood Pressure Monitor

Applicant Shenzhen Pango Electronic Co., Ltd.

K-Number K161845

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HGX 2017-07-31

Youha electric breast pump

Applicant Ningbo Youhe Electrical Appliance Technology Co., Ltd.

K-Number K163136

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KIF 2017-07-31

Obturys

Applicant Itena Clinical

K-Number K170207

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LLZ 2017-07-28

Smart Stitching Software System, Image Processing, Radiological

Applicant Osko, Inc.

K-Number K163048

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MST 2017-07-28

ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA

Applicant Immco Diagnostics, Inc.

K-Number K163177

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IOR 2017-07-28

Wheelchair

Applicant Kunshan Hi-Fortune Health Products Co., Ltd.

K-Number K163352

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GEX 2017-07-28

Photodynamic Therapy Device

Applicant Uvbiotek, LLC

K-Number K170187

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NAY 2017-07-28

da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System

Applicant Intuitive Surgical, Inc.

K-Number K171699

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LCP 2017-07-28

cobas HbA1c Test, cobas b 101 system

Applicant Roche Diagnostics Operations

K-Number K163633

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