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

FXX 2021-10-14

Medical Protective Masks

Applicant Qinhuangdao Taizhi Medical Technology Co., Ltd.

K-Number K212205

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OTJ 2021-10-14

AFS Medical Sterile Single-Use Access Port System

Applicant Afs Medical Co. , Ltd.

K-Number K202688

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EBF 2021-10-14

Vittra APS Unique

Applicant Dentscare Ltda

K-Number K210231

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FMI 2021-10-14

Sterile Hypodermic Needles for Single Use

Applicant Azur Medical Company, Inc.

K-Number K211214

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LZA 2021-10-14

Nitrile Patient Examination Gloves

Applicant Yingxiang Glove Products Co., Ltd.

K-Number K211914

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LOX 2021-10-14

Sapphire NC 24

Applicant OrbusNeich Medical (Shenzhen) Co., Ltd.

K-Number K211807

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LLZ 2021-10-14

SwiftMR

Applicant Airs Medical, Inc.

K-Number K210999

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QAS 2021-10-14

StrokeSENS LVO

Applicant Circle Neurovascular Imaging, Inc.

K-Number K212261

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GWJ 2021-10-14

ALGO 7i

Applicant Path Medical GmbH

K-Number K211147

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PBX 2021-10-14

Family of Venus RF Systems - Venus Freedom

Applicant Venus Concept USA, Inc.

K-Number K211461

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LLZ 2021-10-14

Brainance MD

Applicant Advantis Medical Imaging Single Member P.C.

K-Number K202808

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LZA 2021-10-13

Proclean - Nitrile Powder Free Examination Gloves

Applicant Dr.Boo Company Limited

K-Number K211374

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