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

NBY 2018-10-11

DemeTECH PTFE Nonabsorbable Surgical Suture

Applicant Demetech Corporation

K-Number K181578

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KGN 2018-10-11

NeoMatriX Wound Matrix

Applicant Nextgen Biologics, Inc.

K-Number K181330

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GEI 2018-10-11

Voyant Electrosurgical Generator

Applicant Applied Medical Resources Corp.

K-Number K182244

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NXC 2018-10-11

Ormco Spark Aligner System

Applicant Sybron Dental Specialties

K-Number K182826

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NHA 2018-10-11

Sirona Dental CAD/CAM System

Applicant Dentsply Sirona

K-Number K181520

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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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