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

KPS 2025-03-03

HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4

Applicant Bracco Diagnostics, Inc.

K-Number K243881

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QIH 2025-03-03

LVivo Software Application

Applicant Dia Imaging Analysis, Ltd.

K-Number K243235

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QAS 2025-03-03

JLK-SDH

Applicant JLK, Inc.

K-Number K243611

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GEX 2025-03-03

Q Switched Nd:YAG Laser machine (QNHF-01)

Applicant Beijing Nubway S&T Co., Ltd.

K-Number K242943

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MOS 2025-02-28

16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)

Applicant Quality Electrodynamics

K-Number K244054

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SAH 2025-02-28

MagDI System (MAG-02, DS-01)

Applicant Gt Metabolic Solutions, Inc.

K-Number K243359

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FPA 2025-02-28

Intravascular Extension Sets and Accessories

Applicant Baxter Healthcare Corporation

K-Number K242339

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NAY 2025-02-28

da Vinci SP Advanced Access Port Kit (432701)

Applicant Intuitive Surgical, Inc.

K-Number K243582

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JWH 2025-02-28

MedalOne Total Knee System

Applicant Suzhou Microport Orthorecon Co., Ltd.

K-Number K244039

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IOR 2025-02-28

Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)

Applicant Anhui Jbh Medical Apparatus Co., Ltd.

K-Number K241374

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CAW 2025-02-28

Portable Oxygen Concentrator (P2-TOC)

Applicant Qingdao Kingon Medical Science and Technology Co., Ltd.

K-Number K242718

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QIH 2025-02-28

Myomics

Applicant Phantomics, Inc.

K-Number K241922

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