Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOMEDICS 38 (POLYMACON) UV BLOCKING CONTACT LENSES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC. GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 7278 MAXIMO DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND MODEL 7232 MAXIMO VR SINGLE CHAM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA INTRAOCULAR LENS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT (TIPS, ILIAC, VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·DRILAC CUBES AND GRANULES

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANCURE TUBE AND BIFURCATED SYSTEMS & ILIAC BALLOON CATHETER

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·TAPCATH AND TAPSCOPE DISPOSABLE TRANSESOPHAGEAL PROBES

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·BOSTON SCIENTIFIC MAVERICK 2 PTCA CATHETER

Ultrasound, Hyperthermia, Cancer Treatment

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE 2000 MRI GUIDED FOCUSED ULTRASOUND SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC HALL PROSTHETIC HEART VALVE /HALL EASY FIT

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THINPREP IMAGING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC KAPPA 700/600 PULSE GENERATOR

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EP TECH CARDIAC ABLATION SYSTEM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·OL1000/OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATOR

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·RAPID SCREEN RS-2000, RS-2000D AND RS-DIGITAL

FDA Pre-Market Approval

MEDTRONIC SIGMA/MEDTRONIC 350 SERIES PULSE GENERATORS PRODUCTS

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM

Electrosurgical, Radio Frequency, Refractive Correction

FDA Pre-Market Approval

FDA Class 3 ·VIEWPOINT CK SYSTEM