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

DRG 2026-01-22

Perin Health System (PHD80060-2)

Applicant Perin Health Devices, LLC

K-Number K252984

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QIH 2026-01-22

AI-Rad Companion Brain MR

Applicant Siemens Healthcare GmbH

K-Number K253057

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KGN 2026-01-22

Device 104 Particulate

Applicant Geistlich Pharma AG

K-Number K251323

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SHB 2026-01-21

Nova Max Creat eGFR Monitoring System

Applicant Nova Biomedical Corporation

K-Number K251281

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DQX 2026-01-21

InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)

Applicant Merit Medical Ireland, Ltd.

K-Number K251385

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IYE 2026-01-21

Halcyon, Ethos Radiotherapy System (5.0)

Applicant Varian Medical Systems, Inc.

K-Number K252977

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QEW 2026-01-21

RoVo Mechanical Thrombectomy System

Applicant Verge Medical, Inc.

K-Number K253730

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HRS 2026-01-21

Arthrex Variable Angle (VA) Proximal Tibia Plating System

Applicant Arthrex, Inc.

K-Number K253713

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EBF 2026-01-21

LumiCera

Applicant Hangzhou SHINING3D Dental Technology Co., Ltd.

K-Number K260170

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QFX 2026-01-21

Affirm 400

Applicant Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)

K-Number K251286

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NKG 2026-01-21

Infinity™ OCT System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K254165

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GEX 2026-01-21

Boston Pico755

Applicant Boston Aesthetics, Inc.

K-Number K252369

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