CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR

FDA 510(k)

FDA Class 2 ·Hematology

SICKLE HEMOGLOBIN (HBA/S) CONTROL SET

FDA 510(k)

FDA Class 2 ·Hematology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PAS CHAMPION(TM) CATHETER 30 MM LONG BALLOONS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PROGRESSIVE ANGTIOPLASTY SYSTEMS (PAS) CHAMPION PTCA CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·EXTENSION TO THE PAS LACROSSE PTCA CATHETER PRODUCT LINE

CRANIAL HELMET

FDA 510(k)

FDA Class 2 ·Neurology

MYOSYSTEM WITH CUSTOMIZING

FDA 510(k)

FDA Class 2 ·Neurology

POWERED WHEELCHAIR, MODEL B-500

FDA 510(k)

FDA Class 2 ·Physical Medicine

POWERED WHEELCHAIR, MODEL B-600

FDA 510(k)

FDA Class 2 ·Physical Medicine

POWERED WHEELCHAIR, MODEL C-1000

FDA 510(k)

FDA Class 2 ·Physical Medicine

DESERET MULTILUMEN SUBCLAVIAN JUGULAR

FDA 510(k)

FDA Class 2 ·General Hospital

DESERET THERMODILUTION CARDIAC OUTPUT

FDA 510(k)

FDA Class 2 ·Cardiovascular

DESERET MULTILUMEN SUBCLAVIAN JUGULAR

FDA 510(k)

FDA Class 2 ·General Hospital

Thora-3Di, Model T-01

FDA 510(k)

FDA Class 2 ·Anesthesiology

Magseed Pro Magnetic Marker System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

STERILIZATION PROCESS INDICATOR

FDA 510(k)

FDA Class 2 ·General Hospital

Magseed Magnetic Marker Systtem

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Hypotension Decision Assist

FDA 510(k)

FDA Class 2 ·Cardiovascular

Magseed Magnetic Marker System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BODY COMPOSITION ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular