Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD, Sotlec I, Softec HD PS, Softec HDO, Softec HDM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD; SOFTEC I; SOFTEC HD PS AND SOFTEC HDO IOLS

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·WOLVERINE Coronary Cutting Balloon

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS, CARELINK PROGRAMMER MODEL 2090

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF CRT/ICD'S

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·JEWEL AF, GEM III FAMILY OF ICD'S

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST ICD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·LEGEND PLUS FAMILY OF PACEMAKERS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MICRO JEWELL II ICD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC III CRT-IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 700/600 SIGMA AND ENRYTHM IPG'S

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400 FAMILY OF PACEMAKERS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VITATRON PACEMAKERS

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·HQL Softec HD, Softec I, Softec HD PS, Softec HDO, Softec HDM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves

Analyzer, Data, Obstetric

FDA Pre-Market Approval

FDA Class 3 ·STAN S31 FETAL HEART MONITOR

Analyzer, Data, Obstetric

FDA Pre-Market Approval

FDA Class 3 ·NEOVENTA'S STAN S31 FETAL HEART MONITOR

Analyzer, Data, Obstetric

FDA Pre-Market Approval

FDA Class 3 ·STAN S31 FETAL HEART MONITOR