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

MRH 2026-08-04

OMNI Ultra Surgical System (1-110)

Applicant Sight Sciences, Inc.

K-Number K253760

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OHS 2026-08-04

LED Light Therapy Masks (PE748, PE749, PE756)

Applicant Duplex International Trading Limited

K-Number K261496

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OHS 2026-08-04

LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)

Applicant Shenzhen Qianyu Technology Co., Ltd.

K-Number K261851

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KNW 2026-08-04

Marrow Marxman

Applicant Medimetrix, LLC

K-Number K260572

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QEW 2026-08-04

Vertex™ Thrombectomy System

Applicant Jupiter Endovascular

K-Number K261523

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LPH 2026-08-04

TRIVANCE™ Hip Stem

Applicant Globus Medical, Inc.

K-Number K254043

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QIH 2026-08-04

RealGUIDE

Applicant 3DIEMME SRL

K-Number K253902

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IYN 2026-08-04

Alturion Series Diagnostic Ultrasound System

Applicant Philips Ultrasound, LLC

K-Number K262311

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FED 2026-08-04

Navigator™ Flex Ureteral Access Sheath Set

Applicant Boston Scientific Corporation

K-Number K261915

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HSX 2026-08-04

Freedom Partial Knee System

Applicant Maxx Orthopedics, Inc.

K-Number K261609

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IZQ 2026-08-03

VueJect® Ultrasound Enhancing Agent Delivery System

Applicant ACIST Medical Systems, Inc.

K-Number K262115

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IYE 2026-08-03

Halcyon, Ethos Radiotherapy System (5.0)

Applicant Varian Medical Systems, Inc.

K-Number K261856

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