Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM

Neodent Implant System

FDA 510(k)

FDA Class 2 ·Dental

Neodent Instruments Kits

FDA 510(k)

FDA Class 2 ·General Hospital

Neodent Implant System - GM Line

FDA 510(k)

FDA Class 2 ·Dental

Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants

FDA 510(k)

FDA Class 2 ·Dental

Neodent Implant System-Easy Pack

FDA 510(k)

FDA Class 2 ·Dental

Neodent Implant System – Custom Abutments

FDA 510(k)

FDA Class 2 ·Dental

Neodent Implant System

FDA 510(k)

FDA Class 2 ·Dental

Neodent Implant System - Zirconia Implant System

FDA 510(k)

FDA Class 2 ·Dental

Neodent Implant System-Helix NGM Compact Surgical Kit Cases

FDA 510(k)

FDA Class 2 ·General Hospital

Neodent Implant System- GM Titanium Base for Bridge

FDA 510(k)

FDA Class 2 ·Dental

Neodent Implant System

FDA 510(k)

FDA Class 2 ·Dental

NUVO IF Implant System

FDA 510(k)

FDA Class 2 ·Dental

Neodent Implant System - GM Narrow Implant System

FDA 510(k)

FDA Class 2 ·Dental