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

LNH 2026-03-27

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K253625

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MVL 2026-03-27

CyClean Cord

Applicant SS GLOBAL

K-Number K254239

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HIG 2026-03-27

Asurys Fluid Management System

Applicant Boston Scientific Corporation

K-Number K251273

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GEI 2026-03-27

AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)

Applicant Aventix Medical, Inc.

K-Number K260255

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QLQ 2026-03-27

Synergy Disc Instruments

Applicant Synergy Spine Solutions, Inc.

K-Number K253392

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IYN 2026-03-27

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

Applicant Philips Ultrasound, LLC

K-Number K253595

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HQD 2026-03-27

GPA (hexafocon A) Rigid Gas Permeable Contact Lenses

Applicant Zhuhai Fitlens Medical Technology Co., Ltd.

K-Number K253822

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LNH 2026-03-27

S-scan Open (100001800)

Applicant Esaote, S.p.A.

K-Number K260746

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MAI 2026-03-27

SF Push-in Anchor

Applicant Surgical Fusion Technologies GmbH

K-Number K260294

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ITI 2026-03-27

Power wheelchair (ZS-EW8026)

Applicant Ningbo Zhishan Medical Technology Co., Ltd.

K-Number K254206

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OLO 2026-03-27

SYMPHONY Navigation Ready Instruments

Applicant Medos International SARL

K-Number K260240

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IYN 2026-03-27

Butterfly Gestational Age Tool

Applicant Butterfly Network, Inc.

K-Number K252148

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