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

CAF 2024-05-10

Aerogen®Solo Nebulizer System

Applicant Aerogen, Ltd.

K-Number K232507

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QOF 2024-05-10

QIAstat-Dx® Respiratory Panel Plus

Applicant QIAGEN GmbH

K-Number K233100

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FGB 2024-05-10

Ureterorenoscope System

Applicant Shenzhen HugeMed Medical Technical Development Co., Ltd.

K-Number K240374

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DJG 2024-05-10

Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard

Applicant Guangzhou Decheng Biotechnology Co., Ltd.

K-Number K240698

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GAT 2024-05-10

HyperSuture Extension Line

Applicant Threadstone, LLC

K-Number K234079

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HEB 2024-05-10

Organic Cotton Tampon; Organic Cotton PESCVcord Tampon

Applicant Suzhou Borage Medical Technology Co., Ltd.

K-Number K240708

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KIF 2024-05-10

Bioceramic Root Repair Material (C-Root BP)

Applicant Beijing C-Root Dental Medical Devices Co., Ltd.

K-Number K240365

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OVE 2024-05-10

SCARLET® AC-Ti

Applicant Spineart SA

K-Number K240699

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LNH 2024-05-10

APERTO Lucent MRI System

Applicant FUJIFILM Healthcare Americas Corporation

K-Number K233629

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QFM 2024-05-10

SmartChest

Applicant Milvue

K-Number K232410

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MOL 2024-05-09

Polyisoprene Extra Large Condom

Applicant Suretex Limited

K-Number K232470

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LRK 2024-05-09

Hushd Pro Avera

Applicant Good Sleep CO Pte , Ltd.

K-Number K232025

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