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

DQO 2017-07-21

Progreat

Applicant Ashitaka Factory of Terumo Corporation

K-Number K170223

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FDT 2017-07-21

Fujifilm Duodenoscope Model ED-530XT

Applicant Fujifilm Medical Systems U.S.A, Inc.

K-Number K152257

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LLZ 2017-07-21

Vitrea View

Applicant Vital Images, Inc.

K-Number K163232

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DQX 2017-07-21

True Form Reshapable Guide Wire

Applicant Merit Medical Systems, Inc.

K-Number K170532

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NUC 2017-07-21

External Moisturizing Gel

Applicant Combe Incorporated

K-Number K171855

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MXZ 2017-07-21

BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16

Applicant Leica Biosystems Newcastle, Limited

K-Number K171753

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FRC 2017-07-21

3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader

Applicant 3M Company

K-Number K171003

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HJO 2017-07-21

Portable Slit Lamp Microscope

Applicant Suzhou Kangjie Medical, Inc.

K-Number K162778

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JFY 2017-07-21

Teco Creatinine Enzymatic Reagent Kit

Applicant Teco Diagnostics, Inc.

K-Number K161527

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OZN 2017-07-21

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit

Applicant Luminex Corporation

K-Number K171441

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KWQ 2017-07-20

EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System

Applicant Medos International SARL

K-Number K171439

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FLL 2017-07-20

Microlife Digital Infrared Ear Thermometer

Applicant Microlife Intellectual Property GmbH

K-Number K170219

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