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

QEZ 2021-06-04

AlphaVac Multipurpose Mechanical Aspiration (MMA) System

Applicant AngioDynamics, Inc.

K-Number K211081

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FXX 2021-06-04

Disposable medical mask

Applicant Everwin Toys (Dongguan)., Ltd.

K-Number K203388

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DZE 2021-06-04

Dentis s-Clean s-Line Mini

Applicant Dentis Co., Ltd.

K-Number K210080

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LZA 2021-06-04

Nitrile Patient Examination Gloves

Applicant Huayuan Medical Technology(Shangqiu) Co., Ltd.

K-Number K211028

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NXC 2021-06-04

HIT Clear Aligner

Applicant Cdb Corporation

K-Number K210613

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MQB 2021-06-04

Prudent 1717, Prudent 1417, Prudent 1212

Applicant Pixxgen Corporation

K-Number K211108

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FXX 2021-06-04

Surgical face mask

Applicant Juntech(Jiaxing)Healthcare Materials Co,.Ltd

K-Number K203704

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GEX 2021-06-04

Surgical Green Laser System

Applicant Realton (Suzhou) Medical Technology Co., Ltd.

K-Number K202828

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OMP 2021-06-04

Kendall NPWT Incision Management Device

Applicant Cardinalhealth

K-Number K202217

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FLL 2021-06-04

Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)

Applicant Guandong Genial Technology Co., Limited

K-Number K210014

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MBI 2021-06-04

Fix2Lock (PEEK Self Punching)

Applicant Osteonic Co., Ltd.

K-Number K202763

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IZL 2021-06-04

Micro C Medical Imaging System, M01

Applicant Oxos Medical, Inc.

K-Number K211473

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