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

NFO 2025-09-03

NeurotriS (SX2500); NeurotriS (SX3800)

Applicant A-1 Engineering

K-Number K251909

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GEI 2025-09-03

AGNES Ultra

Applicant Agnes Medical Co., Ltd.

K-Number K250217

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OMC 2025-09-03

SignalNED System (Model RE)

Applicant Forest Devices, Inc.

K-Number K251726

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ONF 2025-09-03

MEDILIGHT

Applicant Medicreations, LLC

K-Number K231952

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GEX 2025-09-03

Diode laser therapy device (VADER)

Applicant Beijing Superlaser Technology Co., Ltd.

K-Number K251457

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IYE 2025-09-03

AquaCast Mask

Applicant Blessing Cathay Corporation

K-Number K252174

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OVD 2025-09-03

IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System

Applicant Alphatec Spine

K-Number K251575

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QIH 2025-09-03

Tempus Pixel

Applicant Arterys, Inc.

K-Number K252539

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DXQ 2025-09-03

AViTA Arm Type Blood Pressure Monitor Cuff

Applicant Avita Corporation

K-Number K250765

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HSN 2025-09-03

Kinos Total Ankle System

Applicant Restor3D

K-Number K252454

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DXN 2025-09-03

Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856)

Applicant Dongguan E-Test Technology Co., Ltd.

K-Number K250231

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EIH 2025-09-03

BruxZir® NOW

Applicant Prismatik Dentalcraft, Inc.

K-Number K252446

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