Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ELCA Laser Catheters

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CVX-300 Excimer Laser System and ELCA Coronary Atherectomy Catheters

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

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

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

FDA Pre-Market Approval

FDA Class 3 ·SONIC ACCELERATED FRACTURE HEALING SYSTEM

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 CONTOUR COCHLEAR IMPLANT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VITESSE TM -E (ECCENTRIC MONORAIL) CATHETER MODEL 120-008

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ELCA CORONARY ATHERECTOMY CATHETERS

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·Nucleus Hybrid L24 Implant System

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM AND TMJ FOSSA-EMINENCE PROSTHESIS

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CVX-300 and CVX-300P Excimer Laser Systems