System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·HER2 FISH PHARMDX KIT

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·HERCEP TEST

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·DAKO HERCEPTEST

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

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors

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