Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·SVS APEX PLUS EXCIMER LASER WORKSTATION

ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)

FDA 510(k)

FDA Class 3 ·Cardiovascular

HOME BLOOD PRESSURE KIT, ANEROID

FDA 510(k)

FDA Class 3 ·Cardiovascular

BALL TIP, MODEL #030-188

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT

FDA 510(k)

FDA Class 3 ·Orthopedic

SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER

FDA 510(k)

FDA Class 3 ·Cardiovascular

GENERATOR, PULSE, IMPLANTABLE

FDA 510(k)

FDA Class 3 ·Cardiovascular

WEDGE TIP, SMALL, MODEL #030-191

FDA 510(k)

FDA Class 3 ·Cardiovascular

RING UPM TOTAL HIP REPLACEMENT

FDA 510(k)

FDA Class 3 ·Orthopedic

WEDGE TIP, SMALL, MODEL #030-194

FDA 510(k)

FDA Class 3 ·Cardiovascular

LITHIUM PACEMAKER 811-811L & 811XL

FDA 510(k)

FDA Class 3 ·Cardiovascular

BALL TIP, MODEL #030-185

FDA 510(k)

FDA Class 3 ·Cardiovascular

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA classification

FDA Class 3 ·Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Automated External Defibrillators (Non-Wearable)

FDA classification

FDA Class 3 ·Automated External Defibrillators (Non-Wearable)

Over-The-Counter Automated External Defibrillator

FDA classification

FDA Class 3 ·Over-The-Counter Automated External Defibrillator