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

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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GEH 2021-01-21

Forwarts

Applicant Pronova Laboratories BV

K-Number K201366

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QEP 2021-01-21

cobas CTNG for use on cobas 6800/8800 systems

Applicant Roche Molecular Systems, Inc.

K-Number K202408

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GDW 2021-01-21

EEA Circular Stapler with Tri-Staple Technology

Applicant Covidien

K-Number K202507

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EIH 2021-01-20

Dentsply Sirona Universal Spray Glazes

Applicant Dentsply Sirona

K-Number K202629

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KLE 2021-01-19

R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose

Applicant Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

K-Number K192913

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GEI 2021-01-19

Potenza

Applicant Jeisys Medical, Inc.

K-Number K201685

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OBJ 2021-01-19

ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter

Applicant Siemens Medical Solutions USA, Inc.

K-Number K203726

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