Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·BOSTON SCIENTIFIC ACE/TRAPPER/SURPASS/REMEDY PTCA CATHETERS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·HYDROGENICS 60 (OCUFILICON F) UV IMT SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR THERMOCOOL

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·BOSTON SCIENTIFIC MAVERICK 2 PTCA CATHETER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR CHAMBER INTRAOCULAR LENS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR DS/NAVISTAR RMT DS/EZ STEER NAV DS/QWIKSTAR DS

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·NELLCOR PURITAN BENNETT INFANT STAR HIGH FREQUENCY VENTILATOR

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS/CELSIUS II DIAGNOSTIC ABLATION DEFLECTABLE TIP CATHETER

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SIDE CATHETER ACCESS PORT KITS/BULK/REFILLS KITS/BULK

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS THERMOCOOL & NAVISTAR THERMOCOOL

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·BD FOCALPOINT GS IMAGING SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY CONTACT LENSES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS CATHETER, NON-TEMPERATURE SENSING ABLATION CATHETERS, INTERFACE CABLES

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SYNVISC (HYLAN G-F 20)

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC HALL PROSTHETIC HEART VALVES A7700 AND M7700

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·AMVISC/AMVISC PLUS SODIUM HYALURONATE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR CATHETER, INTERFACE CABLES

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·BIOLECTRON ORTHOPAK BONE GROWTH STIMULAOR & BIOLECTRON SPINALPAK FUSION STIMULATOR

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MODEL 855 REFILL KIT