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

IYN 2025-09-12

ViewMateTM Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K251820

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DQD 2025-09-12

Stethophone Pro

Applicant Sparrow Acoustics, Inc.

K-Number K252595

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OHS 2025-09-12

LED Light Therapy Mask (2311, 2344, 2457, 2458)

Applicant Dongguan Yanxi Technology Co., Ltd.

K-Number K252189

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HSB 2025-09-12

DynaNail TTC Fusion System

Applicant MedShape, Inc.

K-Number K250628

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NFT 2025-09-12

Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup

Applicant Vivachek Biotech (Hangzhou) Co., Ltd.

K-Number K252554

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GEI 2025-09-12

Legend X Platform

Applicant Pollogen, Ltd.

K-Number K252576

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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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