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

QXN 2026-03-04

LifeVac

Applicant Lifevac, LLC

K-Number DEN250012

View Details →

IYO 2026-03-04

QT Scanner 2000 Model A

Applicant QT Imaging Holdings, Inc.

K-Number K253898

View Details →

ITI 2026-03-04

Electric Wheelchair (MP148)

Applicant Suzhou Master Machinery Manufacturing Co.,Ltd

K-Number K253870

View Details →

PNN 2026-03-04

SureSmile Software

Applicant Dentsply Sirona, Inc.

K-Number K253565

View Details →

DZE 2026-03-04

Dentis SQ-SL AXEL Fixture

Applicant Dentis Co., Ltd.

K-Number K253493

View Details →

FTC 2026-03-04

Klär Lite (RCW-KL1000)

Applicant Radcliffe Watts, LLC

K-Number K253871

View Details →

NUH 2026-03-04

TENS/EMS device (GUSE01)

Applicant Globalcare Medical Technology Co., Ltd.

K-Number K253896

View Details →

OLP 2026-03-04

LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K253878

View Details →

HSB 2026-03-04

Active Intramedullary (AIM) Tibial Nail System

Applicant Satori Orthopaedics, Inc.

K-Number K252025

View Details →

QAS 2026-03-03

Annalise Enterprise

Applicant Harrison-AI Medical Pty, Ltd.

K-Number K253818

View Details →

HRS 2026-03-03

Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button

Applicant Arthrex, Inc.

K-Number K260353

View Details →

GEX 2026-03-03

CO2 Laser Treatment Machine (CFR3M1)

Applicant Haidari Beauty Technology (Beijing) Co., Ltd.

K-Number K253920

View Details →

Page 62 of 2685

↑