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

FDA 2025-09-26

FUJIFILM Stiffening Wire Device (SW-2000)

Applicant FUJIFILM Healthcare Americas Corporation

K-Number K251204

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HCG 2025-09-26

Optima Coil System (Optima Packing Coil System)

Applicant Balt USA, LLC

K-Number K252700

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DXG 2025-09-26

VitalStream ART Connect; VitalStream-Hemo

Applicant Caretaker Medical

K-Number K251275

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JKA 2025-09-25

Steripath® Flow™ Blood Collection System

Applicant Magnolia Medical Technologies

K-Number K251812

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LNH 2025-09-25

uMR 680

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K252371

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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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