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

KPE 2026-01-09

KabiHelp® Uno; KabiHelp® Advance plus

Applicant Fresenius Kabi AG

K-Number K251139

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OXC 2026-01-09

ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)

Applicant Ethicon Endo-Surgery, LLC

K-Number K252906

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CGX 2026-01-09

Nova Allegro UACR Assay, Nova Allegro Analyzer

Applicant Nova Biomedical Corporation

K-Number K252206

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DXQ 2026-01-09

Disposable Neonatal NIBP Cuff (U1681S-C51N)

Applicant Unimed Medical Supplies, Inc.

K-Number K253964

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QQH 2026-01-09

iotaSOFT® Insertion System

Applicant Iotamotion, Inc.

K-Number K252339

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IYN 2026-01-08

LOGIQ Totus

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K253370

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FRO 2026-01-08

revyve® Antimicrobial Skin and Wound Cleanser

Applicant Kane Biotech, Inc.

K-Number K252759

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DRF 2026-01-08

Vision-MR Diagnostic Catheter

Applicant Imricor Medical Systems, Inc.

K-Number K252794

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LLZ 2026-01-08

View

Applicant GE Healthcare

K-Number K253639

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PHX 2026-01-08

Tornier Perform Reversed Monopost Glenoid (Perform Mono)

Applicant Tornier, Inc.

K-Number K252788

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LLZ 2026-01-08

3DICOM MD Cloud

Applicant Singular Health Pty, Ltd.

K-Number K253784

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ODP 2026-01-08

Advantage-C Ti3D Cervical Interbody Fusion Device

Applicant Intelivation Technologies

K-Number K252711

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