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

EBF 2026-06-02

DIAFIL

Applicant DiaDent Group International

K-Number K261093

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GEI 2026-06-02

Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)

Applicant F Care Systems USA, LLC

K-Number K253918

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IPF 2026-06-02

High Tone Power therapy (HiToP) (Model: HiToP PNP)

Applicant Mohammadali Nezakati

K-Number K252816

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JKA 2026-06-02

Female Culture Device; Male Culture Device; Transfer Device; Access Device

Applicant Zhejiang Kindly Medical Device Co., Ltd.

K-Number K252899

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HRS 2026-06-02

Pectus Blu System

Applicant Biomet Microfixation

K-Number K261002

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GEI 2026-06-02

MILAN System

Applicant Lumenis Be, Ltd.

K-Number K253803

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QAU 2026-06-02

Hemospray Endoscopic Hemostat (HEMO-[X])

Applicant Wilson-Cook Medical, Inc.

K-Number K253302

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NKG 2026-06-02

TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems

Applicant ZheJiang Decans Medical Devices Co., Ltd.

K-Number K253195

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IOR 2026-06-02

Manual Wheelchair (LW01108)

Applicant Anhui Longway Medical Technology Co., Ltd.

K-Number K260642

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PHZ 2026-06-02

Tyto Insights for Wheeze Detection (with PCCP)

Applicant Tyto Care , Ltd.

K-Number K252844

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MQV 2026-06-02

Device 300419 Strip

Applicant Geistlich Pharma AG

K-Number K260364

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KDN 2026-06-01

VI°Port™ Liver Preservation System

Applicant Traferox Technologies, Inc.

K-Number K260456

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