inHEART Models

FDA 510(k)

FDA Class 2 ·Radiology

Swift System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VISENSIA, VISENSIA WITH ALERT

FDA 510(k)

FDA Class 2 ·Cardiovascular

moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager

FDA 510(k)

FDA Class 2 ·Cardiovascular

swiftPro System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MOORFLPI FULL-FIELD LASER PERFUSION IMAGER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Trackit T4 EEG Amplifier

FDA 510(k)

FDA Class 2 ·Neurology

MOORLDLS LASER DOPPLER LINE SCANNER

FDA 510(k)

FDA Class 2 ·Cardiovascular

R-40 EEG Amplifier

FDA 510(k)

FDA Class 2 ·Neurology

VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label

FDA 510(k)

FDA Class 2 ·General Hospital

Medical image processing software

FDA 510(k)

FDA Class 2 ·Radiology

LUMEND FRONTRUNNER CTO CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SoundBite Crossing System - Peripheral (14P)

FDA 510(k)

FDA Class 2 ·Cardiovascular

OCELOT CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tigereye CTO-Crossing Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

AXIOS Stent and Electrocautery Enhanced Delivery System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THE CROSSER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

AXIOS STENT AND DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology