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

IPF 2025-09-12

Compact II

Applicant Enraf-Nonius, B.V.

K-Number K251083

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GAT 2025-09-12

PowerKnot High Strength Sutures

Applicant Medacta International S.A.

K-Number K252225

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MQL 2025-09-12

Fast Warm - NX

Applicant Fujifilm Irvine Scientific

K-Number K250445

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IZL 2025-09-12

BONX805

Applicant Bontech Co., Ltd.

K-Number K243864

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LHN 2025-09-12

S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)

Applicant Mevion Medical Systems, Inc.

K-Number K250986

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OLP 2025-09-12

Erchonia EVRL

Applicant Erchonia Corporation

K-Number K251843

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DQK 2025-09-12

Volta AF-Xplorer II

Applicant Volta Medical

K-Number K251518

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MXD 2025-09-12

LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)

Applicant Boston Scientific Corporation

K-Number K252593

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IYN 2025-09-12

FETOLY

Applicant Diagnoly

K-Number K251368

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FBN 2025-09-12

Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller

Applicant Tangent Endoscopy, LLC

K-Number K251170

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OLO 2025-09-12

Spine & Trauma Navigation Instruments

Applicant Brainlab AG

K-Number K252562

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IRT 2025-09-12

bite away two

Applicant mibeTec GmbH

K-Number K250047

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