Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·MOBILEXCIMER FOR PTK AND PRK

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Urinary)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Bowel)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof IQ Aspheric IOL with the UltraSert Pre-Loaded Delivery System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTATIONAL ANGIOPLASTY SYSTEM WITH ROTALINK PLUS EXCHANGEABLE CATHETER/ADVANCER

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR(R) ROTALINK ROTATIONAL ANGIOPLASTY SYSTEM AND ROTALINK(TM) PLUS WITH EXCHANGEABLE CATHETER

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Hepatitis B orfe IgM (aHBcM) Assay

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS Total Knee System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF SINGLE PIECE INTRAOCULAR LENSES

POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10

FDA 510(k)

FDA Class 3 ·Cardiovascular

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR RATATIONAL ANGIOPLASTY SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 6837 & 6839 INDUCTION/MONITOR & 6871 O-RINGS

Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA Pre-Market Approval

FDA Class 3 ·LCS UNICOMPARTMENTAL KNEE SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM, TOTABLATOR LASER WELDING PROCESS