3,137 results · 22ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 3 ·INSYNC II PROTECT, INSYNC III PROTECT, INTRINSIC 30, INTRINSIC, INSYNC SENTRY, INSYNC MAXIMO, CONCERTO

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

FDA Pre-Market Approval
FDA Class 3 ·INSYNC MARQUIS/INSYNC III (MARQUIS)/INSYNC II (MARQUIS)/INSYNC II (PROTECT)/INSYNC MAXIMO/PRODIGY DR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MODEL 7271 GEM DR, MODEL 7273 GEM II DR, MODEL 7275 GEM III DR ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·INSYNC II P ROTECT ICD, INSYNC III MARQUIS ICD, INSYNC MARQUIS ICD, INSYNC MAXIMO ICD

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN LEAD DRUG COMBINATION: 4193 & 4194 ONLY/INSYNC CRT-P/INSYNC III CRT-P

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

FDA Pre-Market Approval
FDA Class 3 ·CONCERTO/CONCERTO II/INSYNC III MARQUIS/ INSYNC MAXIMO/MAXIMOII/PROTECTA/PROTECTA XT/PROTECTA CRT-D

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·SOLUS,ADDVENT,SOLUS II,SYNCHRONY, PHOENIX III, TRIOLOGY, AFFINITY, INTEGRITY, ENTITY,IDENTITY, VERITY, AND VICTORY PACEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·SOLUS, ADDVENT, SOLUS II, SYNCHRONY, PHOENIX III, TRILOGY, AFFINITY, INTEGRITY, ENTITY, IDENTITY, VERITY AND VICTORY PAC

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CONCERTO II/CONSULTA/INSYNC II MARQUIS/III MARQUIS/INSYNC MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·SOLUS, ADDVENT, SOLUS II, SYNCHRONY,PHOENIX III, TRIOLOGY, AFFINITY, INTREGRITY, ENTITY IDENTITY, VERITY AND VICTORY PAC

Lens, Iris Reconstruction

FDA classification
FDA Class 3 ·Lens, Iris Reconstruction

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LIFEVEST (WCD 3100) DEVICE

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

FDA Pre-Market Approval
FDA Class 3 ·THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR

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

FDA Pre-Market Approval
FDA Class 3 ·THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·GEM, GEM II, GEM III, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, ONYX, PROTECTA, SECURA, VIRTUOSO, VITUOSO II, ENTRUST

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

FDA Pre-Market Approval
FDA Class 3 ·THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR

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

FDA Pre-Market Approval
FDA Class 3 ·THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR

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

FDA Pre-Market Approval
FDA Class 3 ·THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR

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

FDA Pre-Market Approval
FDA Class 3 ·THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR

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

FDA Pre-Market Approval
FDA Class 3 ·SAFIRE DUO/COOL PATH DUO ABLATION CATHETERS, VERISENSE ENABLED AND VERISENSE SYSTEM AND IBI 1500T9-CP V1.6 CARDIAC