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

JOW 2016-08-18

Reprocessed Compression Garments

Applicant Covidien

K-Number K161105

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IYN 2016-08-18

SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System

Applicant FUJIFILM Sonosite, Inc.

K-Number K162045

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JLW 2016-08-18

Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems

Applicant Beckman Coulter, Inc.

K-Number K153651

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DXC 2016-08-18

Vein Clamps, Artery Clamps

Applicant Aros Surgical Instruments Corporation

K-Number K161315

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DQX 2016-08-18

S-Wire Guidewire System

Applicant Concert Medical, LLC

K-Number K153397

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DQA 2016-08-18

Fingertip Pulse Oximeter

Applicant Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd.

K-Number K152091

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OCC 2016-08-18

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit

Applicant Alere Scarborough, Inc.

K-Number K161375

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DQA 2016-08-18

Medke Oximetry Finger Sensor

Applicant Shenzhen Medke Technology Co., Ltd.

K-Number K152390

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IYX 2016-08-18

Sentinella 102, Sentinella 102 Horus

Applicant General Equipment For Medical Imaging (Oncovision-

K-Number K162052

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DQA 2016-08-17

Wrist Pulse Oximeter

Applicant Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd.

K-Number K152089

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DJR 2016-08-17

First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)

Applicant W.H.P.M., Inc.

K-Number K160793

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LLZ 2016-08-17

WebPAX

Applicant Heart Imaging Technologies, LLC

K-Number K152949

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