Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

DZE 2025-09-25

JDEvolution Plus L and JDEvolution Plus LE

Applicant Jdentalcare Srl

K-Number K251148

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OLO 2025-09-25

RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer

Applicant Stryker Instruments

K-Number K251971

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NRY 2025-09-25

EMBOTRAP III Revascularization Device

Applicant Neuravi Limited

K-Number K251789

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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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