CorVista® System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Coronary Artery Disease Machine Learning-Based Notification Software

FDA classification

FDA Class 2 ·Coronary Artery Disease Machine Learning-Based Notification Software

Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EXTRAFIX EXTERNAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KALIX II IMPLANT, MODEL 141 0XX WITH XX

FDA 510(k)

FDA Class 2 ·Orthopedic

Curing Light, Model: MaxCure 9

FDA 510(k)

FDA Class 2 ·Dental

Ultrasonic Scaler Tips

FDA 510(k)

FDA Class 2 ·Dental

STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX

FDA 510(k)

FDA Class 2 ·Orthopedic

BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUEX ED; QUEX S

FDA 510(k)

FDA Class 2 ·Neurology

Vdrive system, Vdrive Duo, Vdrive with V-Sono

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR

FDA 510(k)

FDA Class 2 ·Cardiovascular

SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057

FDA 510(k)

FDA Class 2 ·Cardiovascular

HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500

FDA 510(k)

FDA Class 2 ·Cardiovascular

CorPath 200 System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CorPath GRX System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ODYSSEY WORKSTATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

SENSEI CATHETER CONTROL SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular