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STELA MODEL UJ45 PACING LEADS

FDA 510(k)
FDA Class 3 ·Cardiovascular

ECSCOPE 100

FDA 510(k)
FDA Class 2 ·Cardiovascular

doctorgram Stethoscope DES-I

FDA 510(k)
FDA Class 2 ·Cardiovascular

INFINITY CENTRALSTATION WITH INFINITY M300

FDA 510(k)
FDA Class 2 ·Cardiovascular

Eko Electronic Stethoscope System

FDA 510(k)
FDA Class 2 ·Cardiovascular

GORE-TEX TUNNELER

FDA 510(k)
FDA Class 1 ·Cardiovascular

ETHICON* TEMP. CARDIAC PACING WIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.

FDA 510(k)
FDA Class 2 ·Cardiovascular

ACS DEFLECTABLE TIP GUIDE WIRE W/MICROGLIDE(R)COAT

FDA 510(k)
FDA Class 2 ·Cardiovascular

GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

THUMPER

FDA 510(k)
FDA Class 2 ·Cardiovascular

ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

FDA 510(k)
FDA Class 2 ·Cardiovascular

ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS

FDA 510(k)
FDA Class 2 ·Cardiovascular

PulsioFlex Monitoring System with ProAQT Sensor

FDA 510(k)
FDA Class 2 ·Cardiovascular

DIDECO PEDIATRIC ARTERIAL FILTERS

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODEL 1051, MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

Arm-type Fully Automatic Digital Blood Pressure Monitor

FDA 510(k)
FDA Class 2 ·Cardiovascular

CARDIMAX FX-1164

FDA 510(k)
FDA Class 2 ·Cardiovascular

HEARTLINK, MODEL II

FDA 510(k)
FDA Class 2 ·Cardiovascular

PRESSURE MONITORING SET

FDA 510(k)
FDA Class 2 ·Cardiovascular