System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·HEART LASER 2 (HL2)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·SOF-SENSOR GLUCOSE SENSOR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD/ HD PS, Softec I, Softec HDO, Softec HDM IOLs

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX ENDOVASCULAR AAA SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE CARDIOFORM SEPTAL OCCLUDER SHARED HLC IN-LINE DIPPER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD, Sotlec I, Softec HD PS, Softec HDO, Softec HDM

DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER

FDA 510(k)

FDA Class 3 ·Orthopedic

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI OsteoGen Implantable Bone Growth Stimulators

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SpF Implantable Spinal Fusion Stimulators

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·HQL Softec HD, Softec I, Softec HD PS, Softec HDO, Softec HDM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs