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

JXE 2025-03-26

NM-01/CPT neurometer (NM-01/CPT)

Applicant Mde Orvosbiológiai Kutató, Fejleszto,

K-Number K240189

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DSP 2025-03-26

AC3 Range Intra-Aortic Balloon Pump

Applicant Arrow International, LLC

K-Number K250542

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QPF 2025-03-26

EarliPoint System

Applicant Earlitec Diagnostics

K-Number K243891

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ITI 2025-03-26

Electrically powered wheelchair

Applicant Kunshan Hi-Fortune Health Products Co., Ltd.

K-Number K244003

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KDN 2025-03-26

Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)

Applicant Bridge TO Life

K-Number K243840

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QJF 2025-03-26

SnapshotGLO (KB100)

Applicant Kent Imaging, Inc.

K-Number K242669

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MYN 2025-03-26

Rayvolve LN

Applicant AZmed

K-Number K243831

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HRS 2025-03-26

Arthrex Humeral Plating System and Cerclage Button

Applicant Arthrex, Inc.

K-Number K243995

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OHT 2025-03-26

Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)

Applicant Shenzhen Ulike Smart Electronics Co., Ltd.

K-Number K250194

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QEW 2025-03-25

Aventus Thrombectomy System (IM-2100)

Applicant Inquis Medical

K-Number K250668

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PPN 2025-03-25

Bolt Intravascular Lithotripsy (IVL) System

Applicant Bolt Medical, Inc.

K-Number K250225

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MRW 2025-03-24

AERO MIS Facet Fusion System

Applicant Aurora Spine

K-Number K243865

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