Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus 24 Cochlear Implant System

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·Nucleus® Hybrid Cochlear Implant

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval

FDA Class 3 ·Spectranetics Laser Sheaths SLS

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·LDR Spine Mobi-C® Cervical Disc Prosthesis

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval

FDA Class 3 ·XPS™ with Steen Solution™ Perfusate

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 COCHLEAR IMPLANT SYSTEM- CHILDREN

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Glenoid Fossa Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Mobi-C Cervical Disc Prosthesis Two Level

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Mobi-C Cervical Disc Prosthesis (One-Level Indication)

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval

FDA Class 3 ·SPECTRANETICS LASER SHEATH DEVICE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CORDIS SEQUICOR THETA MODELS 233D & 233E

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval

FDA Class 3 ·SPECTRANETICS LASER CATHETERS SLS II LASER SHEATH

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CVX-300 & CVX-300P EXCIMER LASER SYSTEM

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MINI SPEECH PROCESSOR