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

OVE 2018-10-11

MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate

Applicant Ctl Medical Corporation

K-Number K182151

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LFD 2018-10-11

Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray

Applicant Laclede, Inc.

K-Number K180680

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NFO 2018-10-11

NuFACE Trinity

Applicant Carol Cole Company Dba Nuface

K-Number K181008

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LEJ 2018-10-11

Ergoline Prestige 1600 Hybrid Performance

Applicant Jk Holding GmbH

K-Number K180555

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HRS 2018-10-11

AxSOS 3 Ti

Applicant Stryker GmbH

K-Number K181091

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GEI 2018-10-11

SCARLET SRF

Applicant VIOL Co., Ltd.

K-Number K180872

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JEY 2018-10-11

OmniPore DUROMAX Surgical Implants

Applicant Matrix Surgical Holdings, LLC/Matrix Surgical USA

K-Number K180249

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LLZ 2018-10-11

OnePacs System

Applicant Onepacs, LLC

K-Number K181460

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LZA 2018-10-10

SBG Black Nitrile Powder Free Medical Examination Glove

Applicant Showa Best Glove, Inc.

K-Number K180468

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QEW 2018-10-10

ClotTriever Thrombectomy System

Applicant Inari Medical

K-Number K182531

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LZA 2018-10-10

SBG Blue Nitrile Powder Free Medical Examination Glove

Applicant Showa Best Glove, Inc.

K-Number K180467

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DXT 2018-10-10

Sterile High-pressure Angiographic Syringes for Single-use

Applicant Shenzhen Baoan Medical Supplies Co., Ltd.

K-Number K182289

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