Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CHANGE IN MANUFACTURING PROCESS TO CLEAN EYE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 14760 UV ABSORBING POSTERIOR CHAMBER LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TIER A MODELS 24050,24150,25050,25350-125 LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TIER A MODELS 24050,24150,25050,25350-125 LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL 14660 UV ABSORBING POSTERIOR CHAMBER LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACCUTECH SINGLE & THREE PIECE INTRAOCULAR LENSES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER PRIME HTD CARDIAC ABLATION CATHETERS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Blazer Prime HTD cardiac ablation catheter

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER PRIME HTD CARDIAC ABLATION CATHETER

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Minerva Genesys HTA Endometrial Ablation System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER PRIME HTD TEMPERATURE ABLATION CATHETER

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HYDRO-THERMABLATOR(HTA) ENDOMETRIAL ABLATION SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Blazer II Catheter, Blazer II HTD Catheter, Blazer Prime HTD Catheter, and IntellaNav ST Catheter, Sterile Cables

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval

FDA Class 3 ·INOUE-BALLOON Catheter