HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote

FDA 510(k)

FDA Class 2 ·Cardiovascular

ECVUE MAPPING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

iLab Polaris Multi-Modality Guidance System

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005

FDA 510(k)

FDA Class 2 ·Cardiovascular

INFINITY MEGACARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENSITE VELOCITY SYSTEM, MODEL EE3000

FDA 510(k)

FDA Class 2 ·Cardiovascular

LiNA OperaScope Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EP-WORKMATE

FDA 510(k)

FDA Class 2 ·Cardiovascular

RhythmView Workstation

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARTO RMT EP NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

RHYTHMSCAN PRECISION 6000

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUINTON Q-CATH, MODEL 000460

FDA 510(k)

FDA Class 2 ·Cardiovascular

INJECTION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PHYSIOLOG, SERIES 95000

FDA 510(k)

FDA Class 2 ·Cardiovascular

INJEKT FILIFORM INJECTION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUANTIEN Measurement System

FDA 510(k)

FDA Class 2 ·Cardiovascular

LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VIVO

FDA 510(k)

FDA Class 2 ·Cardiovascular

WANG TRANSENDOSCOPIC ASPIRATION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology