Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval

FDA Class 3 ·WAVSTAT (TM) OPTICAL BIOPSY SYSTEM

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·Invenia ABUS Premium, Invenia ABUS Prime

Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval

FDA Class 3 ·OPTICAL BIOPSY(TM) SYSTEM

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·Invenia ABUS 2.0 Automated Breast Ultrasound System

Device, Testicular Hypothermia

FDA Pre-Market Approval

FDA Class 3 ·REPRO-MED - THD

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·INVENIA ABUS-AUTOMATED BREAST ULTRASOUND SYSTEM

Device, Testicular Hypothermia

FDA Pre-Market Approval

FDA Class 3 ·REPRO-MED - THD

Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval

FDA Class 3 ·WAVSTAT OPTICAL BIOPSY SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·MEDTONIC FREESTYLE AORTIC BIOPROSTHESIS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·MICROSULIS MICROWAVE ENDOMETERIAL ABLATION (MEA) SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA)

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval

FDA Class 3 ·LungFit PH

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·CORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A,

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented

FDA Pre-Market Approval

FDA Class 3 ·PROSTHESIS, HIP, HEMI-FEMORAL, METAL

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented

FDA Pre-Market Approval

FDA Class 3 ·PROSTHESIS, HIP, HEMI-FEMORAL, METAL

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·CORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A,

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented

FDA Pre-Market Approval

FDA Class 3 ·PROSTHESIS, HIP, HEMI-FEMORAL, METAL

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented

FDA Pre-Market Approval

FDA Class 3 ·PROSTHESIS, HIP, HEMI-FEMORAL, METAL