VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aco Apache Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

TROCKI BODY VENTRILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Revolution Ascend

FDA 510(k)

FDA Class 2 ·Radiology

HASKEL CPR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ODALYS Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Deep Learning Image Reconstruction

FDA 510(k)

FDA Class 2 ·Radiology

LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)

FDA 510(k)

FDA Class 2 ·General Hospital

Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Apache Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Neuronaute

FDA 510(k)

FDA Class 2 ·Neurology

SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

LUXTEC ACO SERIES 4000 LIGHT SOURCE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CCO SYSTEM MODEL SP1467,SP5567,SP6267

FDA 510(k)

FDA Class 2 ·Cardiovascular

SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Neuronaute Plus

FDA 510(k)

FDA Class 2 ·Neurology

Neuronaute with IceCap 2 & IceCap 2 Small

FDA 510(k)

FDA Class 2 ·Neurology

BAUMER PLATES

FDA 510(k)

FDA Class 2 ·Orthopedic