Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL

AMPHETAMINE/METHAMPHETAMINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664

FDA 510(k)

FDA Class 2 ·Radiology

COCAINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ETHANOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CFR QUANT

FDA 510(k)

FDA Class 2 ·Radiology

HeartSee

FDA 510(k)

FDA Class 2 ·Radiology

MAF Guard

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ACCELERATOR APS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NS 2500 HOLMIUM LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AG-605 BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

NASAL MASK, NASAL MASK, FULL FACE MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

NEUROMED OCTRODE MODEL MNR-88 W/98 ADAPTER NEURO.

FDA 510(k)

FDA Class 2 ·Neurology

KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

DATEX AS/3 PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

PARAGON PORTABLE

FDA 510(k)

FDA Class 2 ·General Hospital

SURGITEK INFUSION STENT SYSTEM*

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AGILON XO Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic