ZYMED HOLTER SCANNER MODEL 2010

FDA 510(k)

FDA Class 2 ·Cardiovascular

MIST ENDOSCOPIC NEEDLES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software License

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cardiovascular Suite 4.2.1

FDA 510(k)

FDA Class 2 ·Cardiovascular

INJEKT CYSTO FLEXIBLE INJECTION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENSITE VELOCITY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Vektor Computational ECG Mapping System (vMap)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENSITE VELOCITY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIAC PERFORMANCE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

RADIANALYZER, MODEL 12710

FDA 510(k)

FDA Class 2 ·Cardiovascular

ASTRONOMER+WITH SLD

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAC-LAB/CARDIOLAB EP/COMBOLAB

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Zio AT ECG Monitoring System, ZEUS System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADVANCED UROSCIENCE INJECTION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EnSite™ X EP System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ultiri Measurement System

FDA 510(k)

FDA Class 2 ·Cardiovascular