Sensor, Electro-Optical (For Cervical Cancer)

FDA Pre-Market Approval

FDA Class 3 ·LUMA CERVICAL IMAGING SYSTEM

Sensor, Electro-Optical (For Cervical Cancer)

FDA Pre-Market Approval

FDA Class 3 ·LUMA CERVICAL IMAGING SYSTEM

Sensor, Electro-Optical (For Cervical Cancer)

FDA Pre-Market Approval

FDA Class 3 ·LUMA CERVICAL IMAGING SYSTEM

Sensor, Electro-Optical (For Cervical Cancer)

FDA Pre-Market Approval

FDA Class 3 ·CERVICAL IMAGING SYSTEM

Sensor, Electro-Optical (For Cervical Cancer)

FDA Pre-Market Approval

FDA Class 3 ·LUMA CERVICAL IMAGING SYSTEM

Sensor, Electro-Optical (For Cervical Cancer)

FDA classification

FDA Class 3 ·Sensor, Electro-Optical (For Cervical Cancer)

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Protege GPS Self-Expanding Peripheral Stent System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX FAMILY OF ICDS AND CRT-DS

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·Neuropace RNS System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·BIOTRONIK SOFTWARE MODULE SWM 600 V.D05U01

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·BRIO NEUROSTIMULATION SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEMNOS(TM)04A CARDIAC PACEMAKER & SWM 600/C00U02

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF CONDUCTR 5 MM (7FR, 8FR TIP), RF CONDUCTR 4 MM (7FR), RF CONTACTR 5 MM (7FR, 8FR TIP), RF CONTACTR 5 MM (7FR, 8FR TIP

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC VAD SYSTEM; SEALED ARTERIAL CANNULAE, 14 MM AND 18 MM GRAFT

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·0.7 MM EXTREME CATHETER

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT SYSTEM (10 MM VENOUS ENDOPROSTHESIS) AND UNISTEP PLUS DELIVERY SYSTEM (12 MM VENOUS ENDOPROSTHESIS)

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Cardiac Resynchronization Therapy Defibrillator (CRT-D) ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PUNCTUA, ENERGEN, INCEPTA, MOM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·BETA-CATH 3.5F SYSTEM - 60 MM