Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D/Amplia MRI Quad CRT-D/ Brava CRT-D/Claria Quad CRT-D/ Brava Quad CRT-D/ Compia MRI Quad CRT-D/ Viva Qua

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

FDA Pre-Market Approval

FDA Class 3 ·DIASORIN ETI MAK-2 PLUS ASSAY

System, Test, Alpha-Fetoprotein, Ria

FDA classification

FDA Class 3 ·System, Test, Alpha-Fetoprotein, Ria

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·ALERE NMP22 URINE COLLECTION KIT

Stent Graft, Bypass, Superficial Femoral Artery

FDA classification

FDA Class 3 ·Stent Graft, Bypass, Superficial Femoral Artery

Stent, Iliac Vein

FDA classification

FDA Class 3 ·Stent, Iliac Vein

Stent, Renal

FDA classification

FDA Class 3 ·Stent, Renal

Transcatheter Septal Occluder (Ventricular)

FDA classification

FDA Class 3 ·Transcatheter Septal Occluder (Ventricular)

Stent, Iliac

FDA classification

FDA Class 3 ·Stent, Iliac

Transcatheter Septal Occluder (Atrial)

FDA classification

FDA Class 3 ·Transcatheter Septal Occluder (Atrial)

Stent, Carotid

FDA classification

FDA Class 3 ·Stent, Carotid

Pulmonary Stent

FDA classification

FDA Class 3 ·Pulmonary Stent

Stent, Superficial Femoral Artery

FDA classification

FDA Class 3 ·Stent, Superficial Femoral Artery

Absorbable Coronary Drug-Eluting Stent

FDA classification

FDA Class 3 ·Absorbable Coronary Drug-Eluting Stent

Extracorporeal Shock Wave Treatment

FDA classification

FDA Class 3 ·Extracorporeal Shock Wave Treatment

Coronary Drug-Eluting Stent

FDA classification

FDA Class 3 ·Coronary Drug-Eluting Stent

Stent, Superficial Femoral Artery, Drug-Eluting

FDA classification

FDA Class 3 ·Stent, Superficial Femoral Artery, Drug-Eluting

Stent, Coronary

FDA classification

FDA Class 3 ·Stent, Coronary

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA classification

FDA Class 3 ·Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

Immunohistochemistry Antibody Assay, C-Kit

FDA classification

FDA Class 3 ·Immunohistochemistry Antibody Assay, C-Kit