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

DYB 2026-02-19

AuST CSP Introducer

Applicant CenterPoint Systems, LLC

K-Number K260163

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FXX 2026-02-19

Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)

Applicant Efofex, Inc.

K-Number K253398

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LLZ 2026-02-19

AS Software Version Asera

Applicant AS Software, LLC

K-Number K260205

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QNQ 2026-02-19

Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe

Applicant CMT Health PTE., Ltd.

K-Number K252814

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OLO 2026-02-19

Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor

Applicant Stryker Leibinger GmbH & Co KG

K-Number K253623

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GAT 2026-02-19

Meniscus Versaflex

Applicant GM Dos Reis Industria e Comercio Ltda.

K-Number K254188

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PNZ 2026-02-19

Acclarent AERA Eustachian Tube Balloon Dilation System

Applicant Acclarent, Inc.

K-Number K253612

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NHN 2026-02-19

Erchonia DPN Laser (Model# EVRL)

Applicant Erchonia Corporation

K-Number K251903

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PLF 2026-02-19

ATLAS™ Expandable Osteotomy Wedge System

Applicant MiRus, LLC

K-Number K252733

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SEI 2026-02-19

Access anti-HBc Total

Applicant Beckman Coulter, Inc.

K-Number K253687

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EHD 2026-02-19

Portable Dental X-ray Device (GT-1)

Applicant Guilin Refine Medical Instrument Co., Ltd.

K-Number K254018

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OLO 2026-02-19

Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)

Applicant Alphatec Spine, Inc.

K-Number K252597

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