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

QPN 2025-01-24

Galen Second Read

Applicant Ibex Medical Analytics , Ltd.

K-Number K241232

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NHN 2025-01-24

Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)

Applicant Wuhan Guangdun Technology Co.,Ltd..

K-Number K241057

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PBX 2025-01-24

Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)

Applicant Indiba S. A. U.

K-Number K241107

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KNW 2025-01-24

Bone Marrow Biopsy Needle

Applicant Zhejiang Curaway Medical Technology Co., Ltd.

K-Number K242322

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KNW 2025-01-24

Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle

Applicant Zhejiang Curaway Medical Technology Co., Ltd.

K-Number K241793

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MAX 2025-01-24

AxCess® Expandable Interbody System

Applicant Elliquence, LLC

K-Number K243739

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HAW 2025-01-24

ClearPoint System (Software Version 3.0)

Applicant ClearPoint Neuro, Inc.

K-Number K243657

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DFC 2025-01-24

Tina-quant Lipoprotein(a) Gen.2 Molarity

Applicant Roche Diagnostics Operations

K-Number K241220

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QNP 2025-01-24

MAGENTIQ-COLO (ME-APDS)

Applicant Magentiq Eye, Ltd.

K-Number K244023

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LDF 2025-01-23

Rotatable Connector (5944RL)

Applicant Shenzhen Launch Electrical Co., Ltd.

K-Number K241199

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MBI 2025-01-23

OTS 25-L (100-5)

Applicant Ots Medical , Ltd.

K-Number K241234

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HTN 2025-01-23

Acu-Sinch Knotless Mini

Applicant Acumed, LLC

K-Number K243624

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