EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CardioInsight Cardiac Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO SPARC SLING SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244

FDA 510(k)

FDA Class 2 ·Immunology

Luja Coudé

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENSITE 3000 SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

RED TOP ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

Flyte

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Evo sEEG System

FDA 510(k)

FDA Class 2 ·Neurology

AVI MODEL 480CM INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

Prophecy Preoperative Navigation Alignment System

FDA 510(k)

FDA Class 2 ·Orthopedic

NAMIC ARIA(TM) INFLATION DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

14F iSLEEVE™ Introducer Set

FDA 510(k)

FDA Class 2 ·Cardiovascular

OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRIMACONNEX CERAMIC ABUTMENTS

FDA 510(k)

FDA Class 2 ·Dental

ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR

FDA 510(k)

FDA Class 2 ·Cardiovascular

TENZCARE SNAP ELECTRODE, NO. 6865

FDA 510(k)

FDA Class 2 ·Neurology

SWEET VERNAL ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

DACOMED PENILE PROSTHESIS SIZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry