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

QIH 2026-03-02

Clarius Ejection Fraction AI

Applicant Clarius Mobile Health Corp.

K-Number K253593

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EWY 2026-03-02

KARL STORZ Mediastinoscopes and Instruments

Applicant Karl Storz SE & CO. KG

K-Number K260003

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GEI 2026-03-02

POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)

Applicant Gyrus Acmi, Inc.

K-Number K252487

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BZG 2026-03-02

MESI mTABLET SPIRO

Applicant Mesi D.O.O.

K-Number K251777

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NEY 2026-03-02

Microwave Ablation Device

Applicant Nanjing Dewen Medical Technology Co., Ltd.

K-Number K252632

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EBG 2026-03-02

FLNT Base and FLNT Temp

Applicant Liaoning Upcera Co., Ltd.

K-Number K253380

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HRS 2026-03-02

VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System

Applicant Synthes GmbH

K-Number K254054

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QIH 2026-02-27

Ligence Heart

Applicant Ligence Uab

K-Number K253535

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DQA 2026-02-27

AViTA Pulse Oximeter (SP61)

Applicant Avita Corporation

K-Number K252448

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MBI 2026-02-27

LigaMend

Applicant Riverpoint Medical, LLC

K-Number K253695

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DXF 2026-02-27

HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)

Applicant Atraverse Medical

K-Number K260292

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GEX 2026-02-27

Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)

Applicant Beijing HuaCheng Taike Technology Co., Ltd.

K-Number K253828

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