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

FPA 2026-06-03

iiSure Infusion Set

Applicant Deka Research and Development

K-Number K261530

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KGN 2026-06-03

Roosin Collagen Dressing

Applicant Roosin Medical Co., Ltd.

K-Number K253974

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PGW 2026-06-02

Cube 4D Navigation System, VirtuEye Pro

Applicant Fiagon GmbH

K-Number K261540

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ONN 2026-06-02

Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee

Applicant Orthalign, Inc.

K-Number K253507

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OLO 2026-06-02

SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments

Applicant Life Spine, Inc.

K-Number K260571

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GCJ 2026-06-02

Inno-Port Disposable Bladed Trocar

Applicant Taiwan Surgical Corporation

K-Number K252532

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EBI 2026-06-02

DB 4000 High Impact Denture Base

Applicant Carbon, Inc.

K-Number K260569

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CAF 2026-06-02

FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)

Applicant FindAir Sp. z o.o.

K-Number K260270

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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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