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

KTT 2025-02-21

Extremity Medical External Fixation System

Applicant Extremity Medical, LLC

K-Number K241563

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POK 2025-02-21

Sonio Suspect

Applicant Sonio

K-Number K243614

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INI 2025-02-21

Powered Mobility Scooter

Applicant Intradin (Shanghai) Machinery Co., Ltd.

K-Number K250027

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HGX 2025-02-21

Wearable breast pump (model W8)

Applicant Shenzhen TPH Technology Co., Ltd.

K-Number K242850

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DZJ 2025-02-21

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

Applicant Materialise NV

K-Number K243637

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NXC 2025-02-20

SparkTM Clear Aligner System

Applicant Ormco Corporation

K-Number K250487

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QAS 2025-02-20

EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)

Applicant Ever Fortune.Ai, Co., Ltd.

K-Number K242821

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GEX 2025-02-20

Medical diode laser systems (CHARISMA, REGAL)

Applicant Reveal Lasers , Ltd.

K-Number K234004

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GKZ 2025-02-20

Alinity h-series System

Applicant Abbott Laboratories

K-Number K243283

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MQK 2025-02-20

SperSort Sperm Sorting Chip (IPG02)

Applicant Ipreg Incorporation

K-Number K241626

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IYN 2025-02-20

NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25)

Applicant Nurodata, Inc.

K-Number K242681

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IYN 2025-02-20

Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)

Applicant Edan Instruments, Inc.

K-Number K250214

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