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

OUR 2025-02-28

DYNAMIS SI Screw System

Applicant Promethean Restorative, LLC

K-Number K243565

View Details →

JKA 2025-02-27

PIVO Pro Needle-free Blood Collection Device

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K-Number K241586

View Details →

FBK 2025-02-27

EzVu Visual Vasopressor injector (EV-19)

Applicant Veol Medical Technologies Pvt , Ltd.

K-Number K241595

View Details →

HRS 2025-02-27

CastleLoc Pectus Bar System

Applicant L&K BIOMED Co., Ltd.

K-Number K243357

View Details →

KNW 2025-02-27

Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)

Applicant Xaga Surgical

K-Number K242128

View Details →

LIT 2025-02-27

Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter

Applicant Brosmed Medical Co., Ltd.

K-Number K243704

View Details →

DSY 2025-02-27

Gelweave Vascular Prostheses

Applicant Vascutek, Ltd.

K-Number K241550

View Details →

NGZ 2025-02-27

The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL

Applicant Thermo Fisher Scientific

K-Number K243738

View Details →

PBX 2025-02-27

XOD Diathermia Radiofrequency Device

Applicant Xod, Inc.

K-Number K242175

View Details →

OWW 2025-02-27

Rotium

Applicant Nanofiber Solutions, LLC

K-Number K250021

View Details →

NKB 2025-02-27

VADER® Pedicle System and VADER®one Pedicle System

Applicant Icotec AG

K-Number K242900

View Details →

MYN 2025-02-27

ChestView US

Applicant Gleamer Sas

K-Number K241620

View Details →

Page 332 of 2685

↑