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 2025-05-28

CoLumboX

Applicant Smart Soft Healthcare AD

K-Number K250367

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MQV 2025-05-28

OsteoFlo HydroFiber

Applicant SurGenTec, LLC

K-Number K243949

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QKB 2025-05-28

TAIMedImg DeepMets

Applicant Taiwan Medical Imaging Co., Ltd.

K-Number K250427

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PBX 2025-05-28

Zionic Pro Max (Radiofrequency)

Applicant Termosalud S.L.

K-Number K243716

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IZL 2025-05-28

Europa (Alternative: AiRTouch) portable X-ray system

Applicant Livermoretech, Inc.

K-Number K244049

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EOQ 2025-05-28

Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1.

Applicant Shenzhen Insighters Medical Technology Co., Ltd.

K-Number K242793

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FRN 2025-05-28

MRidium 3870 MRI Infusion Pump System (3870)

Applicant Iradimed Corporation

K-Number K242752

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BZD 2025-05-28

myAir

Applicant Resmed Corp

K-Number K250624

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NRY 2025-05-28

Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing

Applicant Imperative Care, Inc.

K-Number K243047

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QIH 2025-05-28

Rapid MLS

Applicant Ischemaview, Inc.

K-Number K243378

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EGS 2025-05-28

Disposable Prophy Angle

Applicant Pacific Care Limited

K-Number K240950

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EBF 2025-05-27

BEAUTIFIL II

Applicant Shofu Dental Corporation

K-Number K251578

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