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

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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ITX 2026-07-30

SmartGuide Disposable Guides and Grids

Applicant UC-CARE , Ltd.

K-Number K260161

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IYN 2026-07-30

LOGIQ Focus

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K261835

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MBI 2026-07-30

AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down

Applicant Stryker Endoscopy

K-Number K262369

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CCL 2026-07-30

PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)

Applicant Salter Labs

K-Number K261389

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QIH 2026-07-30

cmAngio® V2.0

Applicant Curemetrix, Inc.

K-Number K260980

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NHB 2026-07-30

SeptAlign (SPLN001)

Applicant Spirair, Inc.

K-Number K260620

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