Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WaveLight Analyzer II, ALLEGRO Topolyzer VARIO, Patient Bed Swivel

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·ALLEGRO Topolyzer VARIO and Patient Bed Swivel

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Zoll R Series

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Bellafill Dermal Filler

FDA Pre-Market Approval

RES-Q(TM) MICRON ICD SYSTEM

FDA Pre-Market Approval

RES-Q(TM) MICRON ICD SYSTEM

FDA Pre-Market Approval

RES-Q(TM) MICRON ICD SYSTEM

FDA Pre-Market Approval

RES-Q(TM) MICRON ICD SYSTEM

FDA Pre-Market Approval

RES-Q(TM) MICRON ICD SYSTEM

FDA Pre-Market Approval

RES-Q(TM) MICRON ICD SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Reply/Esprit (5th generation) Electric Hybrid Module

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS

FDA Pre-Market Approval

RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AUTODELFIA HAFP KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AutoDELFIA hAFP Test System

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AUTODELFIA HAFP TEST SYSTEM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AutoDELFIA hAFP Test System

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·KAMRA INLAY

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·KAMRA INLAY