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

CAW 2026-03-26

DeVilbiss 5 Liter Oxygen Concentrator (555)

Applicant Devilbiss Healthcare, LLC

K-Number K253549

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QDQ 2026-03-26

Lunit INSIGHT DBT (V1.2)

Applicant Lunit, Inc.

K-Number K253796

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HQC 2026-03-25

Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)

Applicant Bausch and Lomb, Incorporated

K-Number K252052

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OWI 2026-03-25

Invictus Bands System

Applicant Alphatec Spine, Inc.

K-Number K253615

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OLO 2026-03-25

CUVIS-joint (CJ150)

Applicant Curexo, Inc.

K-Number K252037

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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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