POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DINABASE (TM)

FDA 510(k)

FDA Class 2 ·Dental

12SL ECG ANALYSIS PROGRAM

FDA 510(k)

FDA Class 2 ·Cardiovascular

DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PHASED ARRAY/BILATERAL QUADRATURE CONTOUR COIL

FDA 510(k)

FDA Class 2 ·Radiology

MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ

FDA 510(k)

FDA Class 2 ·Anesthesiology

SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER

FDA 510(k)

FDA Class 2 ·General Hospital

ARTHROCARE SINUS ELECTROSURGERY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODEL SC-3008 SEQUENTIAL CIRCULATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEITZ HALOGEN OPHTHALMOSCOPE BXA-123

FDA 510(k)

FDA Class 2 ·Ophthalmic

IS-ANTI-SM/RNP (720-270)

FDA 510(k)

FDA Class 2 ·Immunology

MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE)

FDA 510(k)

FDA Class 2 ·Radiology

BIOROOT RCS

FDA 510(k)

FDA Class 2 ·Dental

MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULTRATONE 8+ & 20

FDA 510(k)

FDA Class 2 ·Physical Medicine

EZ CONNECT

FDA 510(k)

FDA Class 2 ·Dental

REPROCESSED BALOON INFLATION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCUMETER THEOPHYLLINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL

FDA 510(k)

FDA Class 2 ·Radiology