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

QIH 2026-07-31

Affinity

Applicant Hermes Medical Solutions AB

K-Number K253835

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DQD 2026-07-31

Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)

Applicant Shanghai Hulu Devices Co., Ltd.

K-Number K261494

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ODG 2026-07-31

EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)

Applicant Olympus Medical Systems Corporation

K-Number K261183

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JWH 2026-07-31

ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)

Applicant Globus Medical, Inc.

K-Number K262251

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JOW 2026-07-31

Flexitouch® Plus Advanced Pneumatic Compression System

Applicant Tactile Medical

K-Number K253555

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MNR 2026-07-31

WatchPAT SW

Applicant Itamar Medical , Ltd.

K-Number K254042

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MQP 2026-07-31

Vertiwedge® Intraosseous System

Applicant Foundation Surgical Group

K-Number K261810

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ONN 2026-07-31

Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)

Applicant Orthalign, Inc.

K-Number K262253

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SCR 2026-07-31

Hearing Aid Feature

Applicant Samsung Electronics Co., Ltd.

K-Number K261187

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OVD 2026-07-31

Interwedge® Standalone Lateral

Applicant Foundation Surgical Group

K-Number K261809

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LLZ 2026-07-31

RadioViewAI

Applicant Neurocareai, Inc. (Dba Savelife.Ai)

K-Number K260936

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QJZ 2026-07-31

VitalFlow Set with Balance™ Biosurface

Applicant Medtronic, Inc.

K-Number K261335

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