HOME-AWAY SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NaviCam Xpress Stomach System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IntraMarX 3D Radiopaque Marker

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MINOLTA PULSOX-3/MINOLTA PULSOX-3I

FDA 510(k)

FDA Class 2 ·Cardiovascular

NaviCam Capsule Endoscope System with NaviCam Stomach Capsule

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IntraMarX Radiopaque Markers

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STRYKER SCOPE/INSTRUMENT HOLDER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

da Vinci Xi Surgical System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STRYKER SCOPE WARMER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOWRIST ONE VESSEL SEALER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

da Vinci Xi Surgical System, da Vinci X Surgical System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Intuitive Surgical EndoWrist Vessel Sealer Extend

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

12 mm Endoscopes and Accessories

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOR 2000

FDA 510(k)

FDA Class 2 ·Neurology