10,000 results
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Sources: EU EUDAMED, US FDA
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Classification: FDA Class 3
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Shockwave Intravascular Lithotripsy System
FDA Pre-Market Approval
FDA Class 3
·Shockwave C2 Intravascular (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·Freezor Catheter, Freezor Xtra Catheter, Freezor MAX Surgical Device, Electrical umbilical cable, Coaxial umbilical cabl
Shockwave Intravascular Lithotripsy System
FDA Pre-Market Approval
FDA Class 3
·Shockwave C2 Intravascular Lithotripsy (IVL) Catheter, VL Generator and Connector Cable Kit, IVL Connector Cable (Replac
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·STINGER ABLATION CATHETER; TEMPLINK EXTENSION CABLE
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·DISPOABLE COVER & EPG SAFETY CABLE
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·External Paulse Generator (EPG) Patient Cable
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MODEL 6960 SWITCHABLE ECG PATIENT CABLE
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·DISPOABLE COVER & EPG SAFETY CABLE
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·CHILLI COOLED ABLATION CATHETER AND CABLE
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·CHILLI COOLED ABLATION CATHETER AND CABLE
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·DISPOABLE COVER & EPG SAFETY CABLE
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·DISPOABLE COVER & EPG SAFETY CABLE
Stimulator, Hypoglossal Nerve, Implanted, Apnea
FDA Pre-Market Approval
FDA Class 3
·Model 2740 and 2740C Cable Interference
Shockwave Intravascular Lithotripsy System
FDA Pre-Market Approval
FDA Class 3
·Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (r
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Electrophysiology Cable; SE-Safire TX, Catheter Extension Cable; Therapy 8mm, Thermistor, Dual 8, Safire TX Ablation Cat
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·BLAZER Solid-Tip Ablation Catheter Cable 10, BLAZER Solid-Tip Ablation Catheter Cable 3, INTELLANAV Ablation Cathet
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Safire TX Ablation Catheter, Safire TX, Catheter Extension Cable, Therapy Dual-8 Ablation Catheter, Cables 16- 17- 1
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·BLAZER II XP CARDIAC ABLATION CATHETER/CABLE/BLAZER II HIGH TORQUE DISTAL (HTD) ABLATION CATHETER/CABLE/BLAZER PRIME
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·Chilli II Cooled Ablation Catheter and Cable
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·BLAZER II CARDIAC ABLATION CATHETER AND CABLE