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 2026-06-18

Synapse PACS (7.6.0)

Applicant FUJIFILM Healthcare Americas Corporation

K-Number K261713

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MUE 2026-06-18

MAMMOMAT B.brilliant (11372950)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K253678

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GXN 2026-06-18

3D MAC Titanium Cranial Plate (TCP) System

Applicant The Surgeon General, Department of the Army (TSG-DA)

K-Number K253116

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QAS 2026-06-18

Vascular Assist Occlusion Triage (VAOT) (v1.0)

Applicant GuideAI Health

K-Number K260729

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ITI 2026-06-18

Power Wheelchair (W5915B, W5915C, W5915D)

Applicant Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

K-Number K253812

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OLO 2026-06-18

CORUS™ Navigation System-GN

Applicant Providence Medical Technology, Inc.

K-Number K261665

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GEI 2026-06-18

Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating

Applicant Stryker Sustainability Solutions

K-Number K260636

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EBF 2026-06-18

SRGC-06

Applicant GC America, Inc.

K-Number K261246

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OVE 2026-06-18

CONDUIT™ ZERO-P™ VA Secured Spacer System

Applicant Avalign Technologies, Inc.

K-Number K252982

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MQB 2026-06-18

VIVIX-S 4386W (FXRD-4386WA)

Applicant Vieworks Co., Ltd.

K-Number K260820

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LZA 2026-06-18

Powder Free Nitrile Examination Gloves Non-Sterile Black

Applicant Kanglongda Vietnam Protection Technology Company Limited

K-Number K253824

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GEX 2026-06-18

Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)

Applicant Micro-Energy Medical Technology Co., Ltd.

K-Number K261701

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