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

JDI 2017-05-10

MALUC™ Total Hip Arthroplasty System

Applicant Surgtech, Inc.

K-Number K162125

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KGN 2017-05-10

ABCcolla Collagen Matrix

Applicant Acro Biomedical Co., Ltd.

K-Number K162348

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KTT 2017-05-10

Orthofix TrueLok Hexapod System (TL-HEX) V2.0

Applicant Orthofix Srl

K-Number K170650

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LFD 2017-05-10

Lubricity

Applicant You First Services, Incorporated

K-Number K163476

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KGE 2017-05-09

Fujifilm Diathermic Slitter (FlushKnife)

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

K-Number K171096

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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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