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

PPW 2026-04-03

Etiometry Platform

Applicant Etiometry, Inc.

K-Number K254066

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KPS 2026-04-03

uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K260524

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NQD 2026-04-02

Tina-quant Cardiac high sensitivity CRP III

Applicant Roche Diagnostics

K-Number K260026

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IYN 2026-04-02

Wireless Probe Type Ultrasound Scanner

Applicant Xuzhou Yongkang Electronic Science Technology Co., Ltd.

K-Number K252709

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GEH 2026-04-02

Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)

Applicant Medical Brands Laboratories B.V.

K-Number K252198

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PBX 2026-04-02

SPECCHIO

Applicant El.En S.P.A.

K-Number K260647

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FOZ 2026-04-02

BD Insyte IV Catheter

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K-Number K252137

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QBV 2026-04-02

SMART M-CELL PRP Concentration System

Applicant Miracell Co., Ltd.

K-Number K250516

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LOX 2026-04-02

FLASH Flex Aorto-Ostial Angioplasty System

Applicant Verge Medical, Inc.

K-Number K254022

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QBV 2026-04-02

SMART M-CELL Bone Marrow Concentration System

Applicant Miracell Co., Ltd.

K-Number K250518

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PHC 2026-04-02

LifeShield Infusion Safety Software Suite

Applicant Icu Medical, Inc.

K-Number K252130

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IRP 2026-04-02

Cryopush Cold Compression Device (A02-P-001)

Applicant Chengdu Cryo-Push Medical Technology Co.,Ltd

K-Number K253076

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