Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform

FDA 510(k)

FDA Class 2 ·Cardiovascular

Acumen Hypotension Prediction Index (HPI) Feature Software

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hypertension Prediction Index (HePI) Algorithm

FDA 510(k)

FDA Class 2 ·Cardiovascular

Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure

FDA 510(k)

FDA Class 2 ·Cardiovascular

Acumen Hypotension Prediction Index (HPI) Algorithm

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPTICATH CENTRAL VENOUS OXIMETRY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CATHETER, THERMAL DILUTION FIBEROPTIC

FDA 510(k)

FDA Class 2 ·Cardiovascular

OXIMETER, IN VIVO CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

POET OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

PreSep Oligon Oximetry Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MARQUETTE SV O2 MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)

FDA 510(k)

FDA Class 2 ·Cardiovascular

HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular