System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·HERCEPTEST

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·DAKO HERCEPTEST

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·GENTLE TOUCH UV (NETRAFILCON) SOFT CONTACT LENSES

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·SVS APEX PLUS EXCIMER LASER WORKSTATION

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·SVS APEX PLUS EXCIMER LASER WORKSTATION

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·EXCIMED(TM) UV200LA LASER SYSTEM

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

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·THUNDER HIGH SCAFFORDING OVER-THE-WIRE AND RAPID EXCHANGE SAPHENOUS VEIN GRAFT STENT SYSTEMS