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

DIO 2016-06-27

Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)

Applicant Guangzhou Wondfo Biotech Co., Ltd.

K-Number K161214

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IYN 2016-06-27

Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System

Applicant Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

K-Number K160853

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DXN 2016-06-24

Digital Blood Pressure Monitor

Applicant Suzhou Sunspiri Co., Ltd.

K-Number K153033

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GEH 2016-06-24

ClariFix Device

Applicant Arrinex, Inc.

K-Number K160669

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MUJ 2016-06-24

Precision Treatment Planning System

Applicant Accuray Incorporated

K-Number K161136

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FMI 2016-06-24

Unifine Pentips/ Unifine Pentips Plus

Applicant Owen Mumford, Ltd.

K-Number K152339

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FAD 2016-06-24

Ultrathane Endoureterotomy Stent Set

Applicant Cook Incorporated

K-Number K160891

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IYE 2016-06-24

Radixact Treatment Delivery System

Applicant Accuray Incorporated

K-Number K161146

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KWT 2016-06-24

SMR Shoulder System

Applicant Lima Corporate S.P.A.

K-Number K161476

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CGA 2016-06-24

Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer

Applicant Infrared Laboratory Systems, LLC (Dba Synermed)

K-Number K153692

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ODP 2016-06-24

AnyPlus® Cervical PEEK Cage System

Applicant GS Medical Co., Ltd.

K-Number K153517

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HAW 2016-06-24

BrightMatter Guide with BrightMatter Pointer

Applicant Synaptive Medical, Inc.

K-Number K160523

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