POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure Sensor

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPTUS OTOSCOPES

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

AirKEE T900

FDA 510(k)

FDA Class 2 ·General Hospital

Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aerus Medical Guardian,model F170A

FDA 510(k)

FDA Class 2 ·General Hospital

LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST

FDA 510(k)

FDA Class 2 ·Cardiovascular

Steerable Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRI CYNOSAR CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

LYSUS INFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Steerable Introducer 12F

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISPOSA-SPEC

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

Z FLEX-270TM STEERABLE SHEATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

RI-MINI

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

Hansen Medical Magellan Robotic Catheter 9Fr

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIOTEC S-4000-CR SECURITY SERIES ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10

FDA 510(k)

FDA Class 2 ·Cardiovascular

EOS Air Cleaner

FDA 510(k)

FDA Class 2 ·General Hospital

MitraClip G4 Steerable Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

HeartLight Deflectable Sheath

FDA 510(k)

FDA Class 2 ·Cardiovascular