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

POW 2026-08-05

Ruthinium Disc

Applicant Dental Manufacturing S.p.A.

K-Number K261456

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N/A 2026-08-05

pVasc Net Mechanical Thrombectomy Device

Applicant Vesalio, Inc.

K-Number K254211

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HAW 2026-08-05

Leksell® Vantage Stereotactic System

Applicant Elekta Solutions AB

K-Number K261932

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OLR 2026-08-05

NaturaJel™ Oral Wound Care Kit

Applicant HCS Innovation, LLC

K-Number K260120

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EZD 2026-08-05

Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).

Applicant Convatec

K-Number K260737

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EZL 2026-08-05

Rusch Latex Gold Foley Catheter

Applicant Teleflex Medical Sdn. Bhd.

K-Number K262056

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HWC 2026-08-05

GFS - Sterile Screws and Top Hat

Applicant T.A.G. Medical Products Corporation, Ltd.

K-Number K253858

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QKQ 2026-08-05

Concentriq AP-Dx

Applicant Proscia, Inc.

K-Number K261380

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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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