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

EOQ 2025-09-05

Ion Endoluminal System (IF1000)

Applicant Intuitive Surgical, Inc.

K-Number K252528

View Details →

HAW 2025-09-05

SOLOPASS 2.0 System

Applicant Intravent Medical Partners

K-Number K251317

View Details →

DXT 2025-09-05

High Pressure Tubing

Applicant Shandong Int Medical Instruments Co., Ltd.

K-Number K244038

View Details →

MJN 2025-09-05

pREBOA-PRO Catheter

Applicant Prytime Medical Devices, Inc.

K-Number K243795

View Details →

MBI 2025-09-05

All-Suture Dual Anchor System

Applicant Suturetech, Inc.

K-Number K250095

View Details →

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

View Details →

QAS 2025-09-04

Rapid Obstructive Hydrocephalus, Rapid OH

Applicant Ischemaview, Inc.

K-Number K251533

View Details →

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

View Details →

HKI 2025-09-04

Optina-4C (MHRC-C1N)

Applicant Optina Diagnostics, Inc.

K-Number K250770

View Details →

QIH 2025-09-04

Careverse CoronaryDoc (Careverse CoronaryDoc)

Applicant Careverse Technology Pte. , Ltd.

K-Number K251656

View Details →

MAX 2025-09-04

Endoskeleton™ Interbody Systems

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K251444

View Details →

SAQ 2025-09-04

Symani Surgical System

Applicant Medical Microinstruments, Inc.

K-Number K251510

View Details →

Page 311 of 14156

↑