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

NXC 2021-01-22

BRIUS Clear Aligners

Applicant Brius Technologies, Inc.

K-Number K202792

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LJS 2021-01-22

Piccolo Medical SmartPICC System

Applicant Piccolo Medical, Inc.

K-Number K200037

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FXX 2021-01-22

Surgical Mask

Applicant Jiangsu Medpure Biological Technology Co., Ltd.

K-Number K202640

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DXN 2021-01-22

EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform

Applicant Edwards Lifesciences, LLC

K-Number K203131

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FPA 2021-01-21

Precision Delivery Infusion Set

Applicant Quest Medical, Inc.

K-Number K202672

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NUC 2021-01-21

pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5

Applicant Pjur Group Luxembourg S.A.

K-Number K200731

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JOW 2021-01-21

Overlapped Compression Therapy

Applicant Jkh Health Co., Ltd.

K-Number K202839

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IZI 2021-01-21

DIR 800

Applicant Aesculap, Inc.

K-Number K202391

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FRA 2021-01-21

AEROCURE-MD

Applicant Aerobiotix, Inc.

K-Number K203189

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FXX 2021-01-21

Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask

Applicant Premier Guard USA, LLC

K-Number K202595

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EOQ 2021-01-21

EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190

Applicant Olympus Medical Systems Corp.

K-Number K201758

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FXX 2021-01-21

Surgical Face Mask

Applicant Jiangxi Feilikang Medical Technology Co., Ltd.

K-Number K202904

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