Implant, Auditory Brainstem

FDA Pre-Market Approval

FDA Class 3 ·Nucleus AB1541 Auditory Brainstem Implant

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 System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER (EPTC) EXT CBL, SAFIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, EXT CBL, S

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ELCA Coronary Atherectomy Catheters

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·PERFLUORON

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Myopore® Sutureless Myocardial Pacing Lead

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy Systems

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Infinity Deep Brain Stimulation (DBS) System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Deep Brain Stimulation Therapy System for Parkinson's Disease

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Infinity Deep Brain Stimulation (DBS) System

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval

FDA Class 3 ·Magtrace/and Sentimag Magnetic Localization System

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval

FDA Class 3 ·Magtrace and Sentimag Magnetic Localization System

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval

FDA Class 3 ·MagtraceTM and Sentimag(R) Magnetic Locatization System