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

IYE 2019-02-27

FibermarX Radiopaque Tissue Marker

Applicant Viscus Biologics, LLC

K-Number K190155

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LLZ 2019-02-27

EzDent-i / E2 / Prora View

Applicant Ewoosoft Co., Ltd.

K-Number K190087

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EKX 2019-02-27

AeroPro Cordless Prophy System

Applicant Premier Dental Company Products

K-Number K180682

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DPW 2019-02-27

FlowMet-R

Applicant Laser Associated Sciences, Inc.

K-Number K182494

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NUH 2019-02-27

PAT (Pain Alleviation Technologies)

Applicant Marchan Medical, LLC

K-Number K182267

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OUO 2019-02-27

uPMR 790

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K183014

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FDA 2019-02-27

FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5

Applicant Fujifilm Corporation

K-Number K183683

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JOW 2019-02-27

Lympha Press Optimal Plus

Applicant Mego Afek AC , Ltd.

K-Number K182003

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GEH 2019-02-26

ClariFix

Applicant Arrinex, Inc.

K-Number K190356

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NGX 2019-02-26

Tyece OTC EMS System

Applicant Tyece , Ltd.

K-Number K183454

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JOJ 2019-02-26

3M Comply Hydrogen Peroxide Chemical Indicator

Applicant 3M Company

K-Number K183211

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LON 2019-02-26

VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 >=64/8 µg/mL)

Applicant bioMerieux, Inc.

K-Number K183360

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