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

MOF 2025-07-17

0.014” Willow Guidewire

Applicant Arbor Endovascular, LLC

K-Number K243756

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MQV 2025-07-17

Device 300423 Granules

Applicant Geistlich Pharma AG

K-Number K251556

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MAX 2025-07-17

MectaLIF 3D Metal

Applicant Medacta International S.A.

K-Number K251016

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DQO 2025-07-17

DualView Catheter

Applicant Terumo Corporation

K-Number K250751

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KPS 2025-07-17

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K251839

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JFT 2025-07-17

Elecsys Cortisol III

Applicant Roche Diagnostics

K-Number K242505

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JXI 2025-07-17

VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)

Applicant Alafair Biosciences

K-Number K251175

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EIA 2025-07-17

K5 Cart, K5 Mount, K5 Swing

Applicant Osstem Implant Company., Ltd. Chair Business

K-Number K251491

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MUE 2025-07-17

HESTIA

Applicant Genoray Co., Ltd.

K-Number K243420

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LNH 2025-07-17

uMR Ultra

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K243547

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MOS 2025-07-17

e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector

Applicant Dxtx Medical, Inc.

K-Number K243428

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KGN 2025-07-16

Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus

Applicant Kerecis Limited

K-Number K251845

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