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

LRK 2019-05-08

SomnoDent Avant

Applicant Somnomed, Inc.

K-Number K183443

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OWQ 2019-05-08

Reprocessed ViewFlex Xtra ICE Catheter

Applicant Stryker Sustainability Solutions

K-Number K182238

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GBM 2019-05-08

Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter

Applicant Teleflexmedical, Inc.

K-Number K183461

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MAX 2019-05-08

UNiD Patient specific 3D printed TLIF cage

Applicant Medicrea International SA

K-Number K190092

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HEX 2019-05-08

Gynescope System

Applicant Illumigyn , Ltd.

K-Number K190187

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MQP 2019-05-08

COLOSSEUM Mesh

Applicant Globus Medical, Inc.

K-Number K190147

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NBW 2019-05-08

GlucoLeader Enhance Blood Glucose Monitoring System

Applicant Hmd Biomedical, Inc.

K-Number K182428

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BZD 2019-05-07

Moore Park Mask

Applicant Resmed, Ltd.

K-Number K183512

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OCU 2019-05-07

Scope ProTech

Applicant Meditech Endoscopy, Ltd.

K-Number K191011

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FDF 2019-05-07

FUJIFILM Endoscope Model EC-760S-V/L

Applicant Fujifilm Corporation

K-Number K190649

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FMI 2019-05-07

SteriCap Mini Needle

Applicant Ocujet, LLC

K-Number K183016

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MLY 2019-05-07

Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray

Applicant Gebauer Company

K-Number K190161

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