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

LPL 2025-09-25

Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable)

Applicant Yung Sheng Optical Co., Ltd.

K-Number K244009

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OVE 2025-09-25

Endeavor™ Stand-Alone Cervical IBF System

Applicant Innovasis

K-Number K250076

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BTR 2025-09-25

Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced

Applicant Covidien, LLC

K-Number K243785

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DQA 2025-09-25

Pulse Oximeter

Applicant Shanghai Berry Electronic Tech Co., Ltd.

K-Number K250837

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KIF 2025-09-25

Root canal repair materials (nRoot BP)

Applicant Enpuno Biotechnology Co., Ltd.

K-Number K251465

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QIH 2025-09-25

Brain WMH

Applicant Quantib B.V.

K-Number K251527

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PCH 2025-09-25

Panther Fusion GI Expanded Bacterial Assay

Applicant Hologic, Inc.

K-Number K251993

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OCX 2025-09-25

Single-Use Biopsy Valve (MAJ-1555)

Applicant Olympus Medical Systems Corporation

K-Number K251997

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GEX 2025-09-25

Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN)

Applicant Wuhan Dimed Laser Technology Co., Ltd.

K-Number K252063

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MZP 2025-09-25

Alinity m HCV

Applicant Abbott Molecular, Inc.

K-Number K252102

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JWH 2025-09-25

Stem Extension Line (U2 Total Knee System—PSA Type)

Applicant United Orthopedic Corporation

K-Number K252725

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DQK 2025-09-25

EnSite™ X EP System

Applicant ABBOTT MEDICAL

K-Number K252013

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