Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart Mini (OSM) system

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SLM-2 SILICONE UV-ABSORBING IOL

System, Imaging, Fluorescence

FDA Pre-Market Approval

FDA Class 3 ·KARL STORZ AUTOFLURESCENCE SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PreVue Pre-loaded System, IPURE Pre-loaded System

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·DRILAC CUBES AND GRANULES

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·DRILAC CUBES AND GRANULES

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·DRILAC{TM} CUBES / GRANULES

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·DRILAC{TM} CUBES

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·DRILAC{TM} CUBES

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·DRILAC CUBES{TM}

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·DRILAC GRANULES

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·SOF-SENSOR GLUCOSE SENSOR

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·FLEX MOBILE BEARING KNEE

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·ANGIOSCULPT PTCA SCORING BALLOON CATHETER,RAPID EXCHANGE (RX0

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SIEMENS MAMMOMAT INSPIRATION FULL - FIELD DIGITAL MAMMOGRAPHY SYSTEM

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·PROLIEVE THERMODILITATION SYSTEM

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·PROLIEVE THERMODILITATION SYSTEM

Applicator, Hyperthermia, Superficial, Rf/Microwave

FDA Pre-Market Approval

FDA Class 3 ·HYPERTHERMIA SYSTEM 100 A