Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus® 24 Cochlear Implant System

Implant, Auditory Brainstem

FDA Pre-Market Approval

FDA Class 3 ·Nucleus® 24 Auditory Brainstem Implant System

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 INFLATABLE PENILE PROSTHESIS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC ABLATION CATHETER (NON-IRRIGATED),SAFIRE ABLATION CATHETER (NON-IRRIGATED)

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·COOLFLOW TUBING IFU

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL, EZ STEER THERMOCOOL NAV CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Chilli II ™ Cooled Ablation Catheter and Cable

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ETHYLENE OXIDE (EO)STERILIZATION EQUIPMENT

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI II COOLED ABLATION SYSTEM & STERILE CABLES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·SMARTABLATE SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II, BLAZER II HTD, BLAZER PRIME HTD

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT THERMOCOOL CATHETER

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Chilli II Cooled RF Ablation System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER THERMOCOOL CATH, EZ STEER THERMOCOOL NAV CATH NAVISTAR RMT THERMOCOOL & THERMOCOOL CATH, THERMOCOOL SMARTTOUCH

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY ABLATION CATHETER INCLUDING BI-DIRECTIONAL CATHETER AND THERAPY 4MM THERNISTOR ABLATION CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Catheter RF Contactr, Catheter RF Enhancr II, RF Conductr MC, RF Marinr, RF Marinr 5F SC/ 5F SCXL, 5F SCXS and 5F SCXXL,