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

HGX 2025-09-25

Hi bebe super (BT-150B)

Applicant Bistos Co., Ltd.

K-Number K251512

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PCH 2025-09-25

Panther Fusion GI Bacterial Assay

Applicant Hologic

K-Number K251868

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JWY 2025-09-25

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL

Applicant Thermo Fisher Scientific

K-Number K252062

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PLF 2025-09-25

Auxano® Wedge Fixation System

Applicant Auxano Medical, LLC

K-Number K251791

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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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