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

QEY 2026-01-20

VariFuse Adjustable Infusion Catheter

Applicant Argon Medical Devices, Inc.

K-Number K251318

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IYN 2026-01-20

Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System

Applicant Canon Medical Systems Corporation

K-Number K253597

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FBN 2026-01-20

Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)

Applicant Scivita Medical Technology Co., Ltd.

K-Number K251338

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DWF 2026-01-20

Clearview Intracoronary Shunts

Applicant Medtronic, Inc.

K-Number K253998

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KPR 2026-01-20

DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector

Applicant Carestream Health

K-Number K250954

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EZL 2026-01-20

Rusch SoftSimplastic Foley Catheters

Applicant Teleflex Medical Sdn. Bhd.

K-Number K252537

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JAK 2026-01-20

uCT 780 with uWS-CT-Dual Energy Analysis

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K253173

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KTT 2026-01-20

Excelsior System

Applicant Blue Ocean Global

K-Number K253291

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HHW 2026-01-20

Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes

Applicant Cooper Surgical

K-Number K253698

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DQK 2026-01-18

CARTO™ 3 EP Navigation System V9.0 with PIU Plus

Applicant Biosense Webster, Inc.

K-Number K254085

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DSA 2026-01-18

Baylis Connector Cable

Applicant Baylis Medical Technologies, Inc.

K-Number K254114

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LOX 2026-01-17

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter

Applicant Medtronic, Ireland

K-Number K251970

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