113 results · 27ms · Sources: EU EUDAMED, US FDA

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·INTELLANAV™ ST Ablation Catheter, BLAZER™ II Temperature Ablation Catheter, BLAZER ™ II HTD Temperature Ablation Cathete

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·IntellaNav ST Ablation Catheter, Blazer II Temperature Ablation Catheter, Blazer II HTD Temperature Ablation Catheter, a

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·BLAZER II TEMPERATURE ABLATION CATHETER, BLAZER II XP TEMPERATURE ABLATION CATHETER, BLAZER PRIME HTD TEMPERATURE ABLATI

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·BLAZER II TEMPERATURE ABLATION CATHETERS AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS USED WITH MAESTRO 3000 CARI

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·BLAZER II, BLAZER II HTD TEMPERATURE ABLATION CATHETERS, BLAZER II XP, BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL E RF, CONTAK RENEWAL 3 RF HE W/CONSULT PROG SFTWR

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS ANTI-HBS TEST SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS HBSAG TEST SYSTEM

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·VNS Therapy System

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LADAR VISION EXCIMER LASER SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·OBALON BALLOON SYSTEM