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

OAT 2021-12-19

ATOZ Mini-Screw

Applicant Mk Meditech, Inc.

K-Number K210559

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LZA 2021-12-18

Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)

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

K-Number K213048

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LZA 2021-12-18

Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)

Applicant Ammex Corporation

K-Number K211457

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LZA 2021-12-18

USA Gloves Nitrile Powder Free Exam Gloves

Applicant Usa Gloves

K-Number K211624

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KCT 2021-12-18

Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray

Applicant Nobel Biocare Services AG

K-Number K212932

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LZA 2021-12-18

Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)

Applicant Yunnan Huazhiyuan Medical Technology Co., Ltd.

K-Number K213051

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HTN 2021-12-17

Arthrex Knotless Mini TightRopes

Applicant Arthrex, Inc.

K-Number K213644

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FXX 2021-12-17

Topwide Surgical Face Mask

Applicant Topwide (Hubei) Medical Products Manufacturer

K-Number K210102

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FMF 2021-12-17

Sterile Syringe for Single Use

Applicant Jiangsu Suyun Medical Material Co., Ltd.

K-Number K210914

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LLZ 2021-12-17

Libby IAAA v1.0

Applicant Dyad Medical, Inc.

K-Number K210931

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JWH 2021-12-17

Physica system

Applicant Lima Corporate S.P.A.

K-Number K213381

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FLL 2021-12-17

Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System

Applicant Circa Scientific, LLC

K-Number K200943

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