Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

OEB 2025-12-03

AVIEW Lung Nodule CAD

Applicant Coreline Soft Co., Ltd.

K-Number K251203

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FYA 2025-12-03

Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)

Applicant Yadu Medical (Henan) Co., Ltd.

K-Number K250564

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DSH 2025-12-03

VitaloJAK Clinic (Model 7100)

Applicant Vitalograph , Ltd.

K-Number K253293

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SCV 2025-12-03

Hugo RAS System

Applicant Covidien, LLC

K-Number K250725

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OLT 2025-12-03

HippoMind (v1.0)

Applicant Hippoclinic

K-Number K251881

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IYN 2025-12-03

Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K251601

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QJI 2025-12-03

Omnipod 5 algorithm

Applicant Insulet Corporation

K-Number K251779

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QJP 2025-12-03

Bendit17 Microcatheter

Applicant Bend IT Technologies, Ltd.

K-Number K252213

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JAD 2025-12-03

GentleBeam (GB1000)

Applicant Voxel Ray Solutions, LLC

K-Number K250692

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NAY 2025-12-02

da Vinci SP Surgical System (SP1098)

Applicant Intuitive Surgical, Inc.

K-Number K252069

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QIH 2025-12-02

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Applicant Mighty Oak Medical

K-Number K252103

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NGT 2025-12-02

0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe

Applicant Becton, Dickinson and Company

K-Number K250884

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