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

DQA 2017-05-09

Oxitone 1000

Applicant Oxitone Medical , Ltd.

K-Number K163382

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DYB 2017-05-09

EpiAccess System

Applicant Epiep, Inc.

K-Number K170831

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LZA 2017-05-09

Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)

Applicant Zibo Chengxun Automatic Device Co., Ltd.

K-Number K170393

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BZK 2017-05-09

ExSpiron 1Xi

Applicant Respiratory Motion, Inc.

K-Number K162131

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NJM 2017-05-09

Alpha Pure

Applicant Koroad America

K-Number K163117

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DYB 2017-05-09

Guider Catheter Introducer

Applicant Rhythm Xience, Inc. (Rxi)

K-Number K171081

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KDI 2017-05-09

NxStage System One Plus

Applicant Nxstage Medical, Inc.

K-Number K170469

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DXN 2017-05-09

Digital Blood Pressure Monitor-Automatic Upper Arm Style

Applicant Shenzhen Combei Technology Co., Ltd.

K-Number K163606

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JAK 2017-05-09

Ablation Confirmation

Applicant Neuwave Medical, Inc.

K-Number K171022

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KWQ 2017-05-09

Ocata Anterior Cervical System

Applicant Kalitec Direct, LLC

K-Number K170342

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GEX 2017-05-08

Venus Silk.expert

Applicant Cyden Limited

K-Number K170734

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LJL 2017-05-08

Resultz Lice & Egg Removal Kit

Applicant Piedmont Pharmaceuticals, LLC

K-Number K151562

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