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

LHN 2026-03-25

S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)

Applicant Mevion Medical Systems, Inc.

K-Number K253406

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BZE 2026-03-25

Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)

Applicant Medline Industries, LP

K-Number K253322

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FMI 2026-03-25

Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle

Applicant Sandstone Medical (Suzhou), Inc.

K-Number K252908

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FRO 2026-03-25

MiraChlor Antimicrobial Wound Solution

Applicant Letus Corporation

K-Number K252023

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EOB 2026-03-25

Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)

Applicant Zhuhai Wesee Meditech Co., Ltd.

K-Number K253184

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GEI 2026-03-25

LYNX COBLATION Laryngeal Wand (72290254)

Applicant ArthroCare Corporation

K-Number K253680

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HRS 2026-03-25

Airlock® Ankle Plating System

Applicant Novastep SAS

K-Number K260274

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ODP 2026-03-25

Flex-Z™ Cervical Cage

Applicant Spinepoint, LLC

K-Number K252432

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HRS 2026-03-25

Vortex5 Tailor's Bunion Correction System

Applicant Nvision Biomedical Technologies, Inc.

K-Number K260291

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DQO 2026-03-25

Arterial Pressure Monitoring Set/Tray

Applicant Spectrum Vascular

K-Number K254278

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QXA 2026-03-24

FebriDx Bacterial/Non-bacterial Assay

Applicant Lumos Diagnostics, Inc.

K-Number K260787

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ITI 2026-03-24

Electric Wheelchair (E201)

Applicant Nanjing CareMoving Rehabilitation Equipment Co.,Ltd

K-Number K254012

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