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

MNR 2025-09-05

WatchPAT400 (WP400)

Applicant Itamar Medical , Ltd.

K-Number K250460

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KGI 2025-09-05

3D-SHAPER

Applicant 3D-Shaper Medical S.L

K-Number K251022

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QYT 2025-09-05

GenaCheck COVID-19 Rapid Self-Test

Applicant Genabio Diagnostics, Inc.

K-Number K251753

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LJT 2025-09-05

Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port

Applicant Bard Access Systems, Inc.

K-Number K252478

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EOQ 2025-09-05

Ion Endoluminal System (IF1000)

Applicant Intuitive Surgical, Inc.

K-Number K252528

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HAW 2025-09-05

SOLOPASS 2.0 System

Applicant Intravent Medical Partners

K-Number K251317

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DXT 2025-09-05

High Pressure Tubing

Applicant Shandong Int Medical Instruments Co., Ltd.

K-Number K244038

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MJN 2025-09-05

pREBOA-PRO Catheter

Applicant Prytime Medical Devices, Inc.

K-Number K243795

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MBI 2025-09-05

All-Suture Dual Anchor System

Applicant Suturetech, Inc.

K-Number K250095

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IYN 2025-09-05

ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02)

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K251250

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QAS 2025-09-04

Rapid Obstructive Hydrocephalus, Rapid OH

Applicant Ischemaview, Inc.

K-Number K251533

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ONO 2025-09-04

Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)

Applicant Clinical Laserthermia Systems, AB

K-Number K251298

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