100 results · 18ms · Sources: EU EUDAMED, US FDA

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·FREEZOR CARDIAC CRYOABLATION CATHETER/ FREEZOR XTRA & MAX SURGICAL CRYOABLATION & CCT.2 CRYOCONSOLE SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·ARTIC FRONT CARDIC CRYOABLATION CATHETERS, ARTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETERS, FREEZOR MAX CARIAC CRYOAB

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·FREEZOR CARDIAC CRYOABLATION CATHETER/FREEZOR XTRA & FREEZOR MAX SURGICAL CRYOABLATION DEVICES & CCT.2 CRYOCONSOLE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·7F FREEZOR CARDIAC CRYOABLATION CATHETER & XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, 9F FREEZOR MAX SURGICAL CARDIAC

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

FDA Pre-Market Approval
FDA Class 3 ·ARCTIC FRONT CARDIAC CRYOABLATION SYSTEM: 23MM AND 28MM ARCTIC FRONT CATHETERS, FREEZOR MAX CATHETER, CRYOCONSOLE, MANUA

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter, 9F Freezor MAX Cardiac Cryoabla

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

FDA Pre-Market Approval
FDA Class 3 ·FREEZOR MAX CARDIAC CRYOABLATION CATHETER, AROTIC FRONT/AROTIC FRONT ADVANCE /AROTIC FRONT ADVANCE ST CARDIAC CRYOABLATI

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·FREEZOR CARDIAC CRYO ABLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYO ABLATION DEVICE, FREEZOR MAX SURGICAL CARDI

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·FREEZOR CARDIAC CRYOABLATION CATHETERS/FREEZOR XTRA & FREEZOR MAX SURGICAL CRYOABLATION DEVICES& CCT.2 CRYOCONSOLE SYSTE

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, ENPULSE E1 IPG, ENPULSE E2 IPG,KAPPA D (KAPPA 700) IPG, KAP

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,AT500 DDDRP PACING SYSTEM IPG, ENPULSE E2 IPG,ENPULSE E2 IPG,KAP

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENTRUST ICD,INTRINSIC 30 ICD, INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD, KAPPA DR(KAPPA 700/600)IPG, KAP

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EVERA S DR ICD, S VR ICD, XT DR ICD, XT VR ICD; INTRINSIC ICD; MARQUIS DR ICD, VR ICD; MAXIMO DR ICD, MAXIMO II ICD, MAX

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Max