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

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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NBC 2026-02-18

Alere NT-proBNP for Alinity i

Applicant Axis-Shield Diagnostics, Ltd.

K-Number K253539

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MBH 2026-02-18

Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K-Number K253637

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MEG 2026-02-18

PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)

Applicant Methyl Co., Ltd.

K-Number K252098

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GCJ 2026-02-18

1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality

Applicant Stryker Endoscopy

K-Number K260185

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GEX 2026-02-18

BTL-754FF

Applicant BTL Industries, Inc.

K-Number K252561

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