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

MQL 2017-05-24

Gems Vitrification Set, Gems Warming Set

Applicant Genea Biomedx Pty, Ltd.

K-Number K162409

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LZA 2017-05-24

Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr

Applicant Shen Wei USA, Inc.

K-Number K170290

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DRS 2017-05-24

HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit

Applicant Smiths Medical Asd, Inc.

K-Number K163172

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LYY 2017-05-24

Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein

Applicant Terang Nusa Sdn Bhd

K-Number K170779

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OWB 2017-05-24

AS-10, CXDI-401RF

Applicant Canon, Inc.

K-Number K171194

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OCT 2017-05-24

VitreOx Anti-fog Solution

Applicant Sio2 Nanotech, LLC

K-Number K163257

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LLZ 2017-05-24

vascuCAP

Applicant Elucid Bioimaging, Inc.

K-Number K163071

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DZE 2017-05-24

Dental Implants OKTAGON Bone Level Tapered Design

Applicant Hager& Meisinger GmbH

K-Number K170287

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GEH 2017-05-24

truFreeze System

Applicant CSA Medical, Inc.

K-Number K163244

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LLZ 2017-05-24

UNiD Spine Analyzer

Applicant Medicrea International

K-Number K170172

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HFE 2017-05-24

Tao Brush I.U.M.C. Endometrial Sampler

Applicant Cook Incorporated

K-Number K170603

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PDU 2017-05-24

RA-308 Excimer Laser System, Excimer Laser Catheter

Applicant Ra Medical Systems,Inc

K-Number K170349

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