77 results · 21ms · Sources: EU EUDAMED, US FDA

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM

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

ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER

FDA 510(k)
FDA Class 3 ·Unknown

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·SJM BIOCOR VALVE AND SJM BIOCOR SUPRA VALVE

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·SJM EPIC VALVE AND SJM EPIC SUPRA VALVE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·SJM PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·SJM ICDS

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

FDA Pre-Market Approval
FDA Class 3 ·SJM CRTDS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·SJM ICDS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·SJM LEADS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·SJM LEADS

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·SJM PACEMAKERS

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·SJM™ Masters Series Mechanical Heart Valve, SJM Regent™ Mechanical Heart Valve, SJM™ Masters Series Aortic Valved Graft

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·SJM MRI Activator

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·SJM PYROLYTIC CARBON