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

GEX 2024-12-20

Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)

Applicant Beijing Adss Development Co., Ltd.

K-Number K241670

View Details →

NXC 2024-12-20

Fas Aligner System

Applicant Xplora 3D Europe S.L

K-Number K242929

View Details →

INI 2024-12-20

Scooter (PS30)

Applicant Lichtmega Technology Co., Ltd.

K-Number K242628

View Details →

IYN 2024-12-20

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K242168

View Details →

JWH 2024-12-20

Cellbrick Knee Spacer

Applicant United Orthopedic Corporation

K-Number K243024

View Details →

QOF 2024-12-20

DASH® SARS-CoV-2 & Flu A/B Test

Applicant Nuclein, LLC

K-Number K241652

View Details →

FGE 2024-12-20

Single-use Balloon Dilatation Catheter

Applicant Leo Medical Co., Ltd.

K-Number K241888

View Details →

PEN 2024-12-20

BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

Applicant Biofire Diagnostics, LLC

K-Number K243759

View Details →

LCX 2024-12-20

iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip

Applicant Andon Health Co, Ltd.

K-Number K241394

View Details →

DTM 2024-12-20

KIDS Arterial Filters

Applicant Sorin Group Italia S.R.L.

K-Number K242953

View Details →

LLZ 2024-12-20

Lightning Viewer

Applicant Nexsys Electronics Inc. Dba Medweb

K-Number K242362

View Details →

MWI 2024-12-20

Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)

Applicant Welch Allyn, Inc.

K-Number K241411

View Details →

Page 377 of 2685

↑