GSP Neonatal Creatine Kinase - MM kit

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TALON BALLOON DILATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEXIMA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CODMAN FLEXIBLE ENDOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODEL 8800 CARDIORESPIRATORY OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONCORDE VBR SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MCL 30 DERMABLATE ER:YAG LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS

FDA 510(k)

FDA Class 2 ·Dental

SHASER V-MINI 2 HAIR REMOVAL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

H&H EMERGENCY CRICOTHYROTOMY KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

GENZYME DIRECT AMYLASE VERIFIER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)

FDA 510(k)

FDA Class 2 ·General Hospital

truFreeze System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WELL@HOME SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIS ENGINE

FDA 510(k)

FDA Class 2 ·Neurology

THD SLIDE ONE

FDA 510(k)

FDA Class 2 ·Radiology

SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular