Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMS

Applicator, Hyperthermia, Interstitial

FDA Pre-Market Approval

FDA Class 3 ·VH8500 HYPERTHERMIA TREATMENT SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval

FDA Class 3 ·RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS 1S & 1P

Fluid, Hysteroscopy

FDA Pre-Market Approval

FDA Class 3 ·HYSKON (32% DEXTRAN 70)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TENNANT(TM) & KELMAN(TM) TYPE II

Ceramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses

FDA Pre-Market Approval

FDA Class 3 ·PLASMA SEPARATION SYSTEM

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·REFLECTION CERAMIC ACETABULAR SYSTEM

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·DRILAC CUBES{TM}

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANCURE(TM) TUBE SYSTEM, ANCURE(TM) BIFURCATED SYSTEM

Kit, Assay, Estrogen Receptor

FDA Pre-Market Approval

FDA Class 3 ·RIANEN 3H

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·AIS EXIMER LASER ANGIOPLASTY

Monitor, Intracranial Pressure, Implanted

FDA Pre-Market Approval

FDA Class 3 ·COSMAN ICP TELE-SENSOR(R)

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·ANIMAS VIBE SYSTEM

Barrier, Adhesion, Cardiovascular

FDA Pre-Market Approval

FDA Class 3 ·REPEL-CV BIORESORBABLE ADHESION BARRIER

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·EBK