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

KPO 2026-01-29

NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K253462

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OUR 2026-01-29

Falco Fusion System

Applicant Mcnicoll Surgical, Inc.

K-Number K253611

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DJG 2026-01-29

Labcorp Fentanyl Urine Visual Test

Applicant Medtox Diagnostics, Inc.

K-Number K252684

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EZD 2026-01-29

EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits

Applicant HR Healthcare

K-Number K251274

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IOR 2026-01-29

Manual Wheelchair (W50)

Applicant Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.

K-Number K253632

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QIH 2026-01-29

Surgical Reality Viewer

Applicant Medicalvr B.V.

K-Number K252091

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NHA 2026-01-29

Multi-Unit DAS System

Applicant Talladium España, SL

K-Number K243732

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GCJ 2026-01-29

Medical Shaver System (Morcellator) (YSB-IIIA)

Applicant Hangzhou Hawk Optical Electronic Instruments Co., Ltd.

K-Number K251923

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INI 2026-01-29

Electric Scooter (Mojo-T580)

Applicant Dongguan Smarfody Mobility Technology Co., Ltd.

K-Number K252347

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MBI 2026-01-29

Y-Knotless™ Flex Anchors

Applicant Conmed Corporation

K-Number K253763

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INI 2026-01-29

Electric Scooter (DDF100)

Applicant Zhejiang Nysin Medical Co., Ltd.

K-Number K252275

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SCS 2026-01-29

UV Smart D60

Applicant UV Smart Technologies B.V.

K-Number K251354

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