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

QAS 2026-09-16

a2z-Abdo-Triage

Applicant A2z Radiology Ai, Inc.

K-Number K260906

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IOR 2026-09-16

Multifunctional wheelchair (YJ-059)

Applicant Zhenjiang Assure Medical Equipment Co., Ltd.

K-Number K261919

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QJI 2026-09-16

iOS CamAPS FX

Applicant CamDiab

K-Number K261896

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PNO 2026-09-16

JADE SCORE PTA Scoring Balloon Dilatation Catheter

Applicant OrbusNeich Medical (Shenzhen) Co., Ltd.

K-Number K261778

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ITI 2026-09-16

Electric Wheelchair

Applicant Yongkang Joymax Medical Technology Co., Ltd.

K-Number K262054

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ELW 2026-09-16

Dia-X Sil Heavy Body

Applicant DiaDent Group International

K-Number K254142

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MOF 2026-09-16

Aristotle 65 Macrowire

Applicant Scientia Vascular

K-Number K254181

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BZK 2026-09-16

ElintMAX Respiratory Monitor (ElintMAX Monitor A1)

Applicant Amptron Medical, Inc.

K-Number K260226

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GEX 2026-09-16

SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)

Applicant Olympus Surgical Technologies America

K-Number K262877

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SHI 2026-09-16

ClearClub Impression Material

Applicant ClearClub

K-Number K261888

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NFO 2026-09-16

LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))

Applicant Guangdong Newdermo Biotech Co., Ltd.

K-Number K261370

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EOQ 2026-09-16

Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set

Applicant Ambu A/S

K-Number K260309

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