Achieva 1.5T, 3.0T and Intera 1.5T MR Systems

FDA 510(k)

FDA Class 2 ·Radiology

O-MAR

FDA 510(k)

FDA Class 2 ·Radiology

CONTEC DUO, CONTEC LC, CONTEC LCR

FDA 510(k)

FDA Class 2 ·Dental

MultiBand SENSE

FDA 510(k)

FDA Class 2 ·Radiology

Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems

FDA 510(k)

FDA Class 2 ·Radiology

MultiBand SENSE

FDA 510(k)

FDA Class 2 ·Radiology

Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4

FDA 510(k)

FDA Class 2 ·Radiology

Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei

FDA 510(k)

FDA Class 2 ·Radiology

mDIXON XD

FDA 510(k)

FDA Class 2 ·Radiology

CONTEC LIGHT

FDA 510(k)

FDA Class 2 ·Dental

Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems

FDA 510(k)

FDA Class 2 ·Radiology

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Epic™ Supra Valve, Epic™ Valve, Epic™ Plus Stented Tissue Valve, Epic™ Plus Supra Valve, Epic™ Max Valve

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Catheter, Arctic Front Advance Catheter, Arctic Front Advance ST Catheter, Freezor MAX Catheter, Manual ret

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Cardiac CryoAblation System: Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoabl

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Cardiac CryoAblation System: Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoabl

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Epic, Epic Supra, Epic Plus, Epic Plus Supra, Epic Max, Portico, Navitor, and Navitor Titan Tissue Heart Valves

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Epic, Epic Supra, Epic Plus, Epic Plus Supra, Epic Max, Portico, Navitor, and Navitor Titan Tissue Heart Valves

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERCARDIAL BIOPRSTHESIS MODELS 7300 AND 7300TFX

Wax, Bone

FDA classification

FDA Unclassified ·Wax, Bone

Device, Jaw Tracking, For Monitoring Jaw Positions

FDA classification

FDA Class 1 ·Device, Jaw Tracking, For Monitoring Jaw Positions