1,603 results · 31ms · Sources: EU EUDAMED, US FDA

QSI 9500

FDA 510(k)
FDA Class 2 ·Neurology

QSI 9000

FDA 510(k)
FDA Class 2 ·Neurology

ASI Automated ASI RPR Test for Syphilis on the ASI Evolution

FDA 510(k)
FDA Class 2 ·Microbiology

ASI REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ASI Evolution

FDA 510(k)
FDA Class 2 ·Microbiology

DIO SM IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·CSI COLOURS CONTACT LENSES

ASI Plethysmogrpah Analyzer

FDA 510(k)
FDA Class 2 ·Cardiovascular

ASI HEMOSTASIS CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ASI CYSTOLASE LASER CYSTOSCOPE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ASI UROPLASTY LASER CYSTOSCOPE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

AIRPREP SYSTEM - MODEL 9001

FDA 510(k)
FDA Class 2 ·Dental

ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES

FDA 510(k)
FDA Class 2 ·Dental

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·CSI (CROFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS

AUTO-SAFETY INJECTOR-2 (ASI-2)

FDA 510(k)
FDA Class 2 ·General Hospital

ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

DSI Dental Implant System

FDA 510(k)
FDA Class 2 ·Dental

DIO IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

SM-EXTRA WIDE (RBM) IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer

FDA 510(k)
FDA Class 2 ·Microbiology