Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 5038 CAPSURE VDD-2 LEAD

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW BONE CEMENT, CMW 1, CMW 1 RADIOPAQUE, CMW 2, AND CMW 3 BONE CEMENTS.

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (LVAS)

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW 1 RADIOPAQUE, CMW2 AND CMW3 BONE CEMENTS

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW BONE CEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW BONE CEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW BONE CEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW BONE CEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW BONE CEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW BONE CEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW BONE CEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW BONE CEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW BONE CEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW BONE CEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW ORTHOPEDIC BONE CEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW ORTHOPAEDIC BONE CEMENT

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE 2000 XPI ANTI-HBC IMG

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW(TM)2 QUICK SETTING BONE CEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW(TM) RADIOPAQUE BONE CEMENT, HALF PACK

Wheelchair, Stair Climbing

FDA Pre-Market Approval

FDA Class 2 ·INDEPENDENCE (TM) IBOT 3000/4000 MOBILITY SYSTEM