Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS COCHLEAR IMPLANT SYSTEMS

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·RESTORE ULTRA NEUROSTIMULATOR, RESTORE SENSOR NEUROSTIMULATOR, ITREL 4 NEUROSTIMULATOR AND ENTERNAL NEUROSTIMULATOR

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA PC NEUROSTIMULATOR, ACTIVA SC NEUROSTIMULATOR, ACTIVA RC NEUROSTIMULATOR AND EXTERNAL NEUROSTIMULATOR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DA+C & DA+T SERIES

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS Therapy System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRESTIGE LP Cervical Disc

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DA+ C-SERIES AND DA+ T-SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DA+ C-SERIES & DA+ T-SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DA+C SERIES & DA+T SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VITATRON DA+C-SERIES/VITATRON DA+T SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VITATRON DA + C-SERIESAND VITATRON DA + T-SERIES

System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

FDA Pre-Market Approval

FDA Class 3 ·ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08)