10,000 results · 39ms · Sources: EU EUDAMED, US FDA

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·MOSIAC PORCINE BIOPROSTHESIS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SYNCHROMED II PUMP

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·PACEMAKER ICD CRT NON IMPLANTED COMPONENTS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SYNCHROMED IMPLANTABLE INFUSION PUMPS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·REVO MRI SURESCAN IPG

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval
FDA Class 3 ·TMR HOLMIUM LASER SYSTEM

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval
FDA Class 3 ·Infuse Bone Graft

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Bioprosthesis

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DEXTRUS STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEADS MODELS 4135,4136 & 4137

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SynchroMed Infusion System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SynchroMed™ Infusion System

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NEUROPACE RNS SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EnVeo R and EnVeo PRO delivery catheter system (DCS)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·Mara Water Vapor Ablation System

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

FDA Pre-Market Approval
FDA Class 3 ·PSW 2100.U and NEO 2100.U

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented

FDA Pre-Market Approval
FDA Class 3 ·PROSTHESIS, HIP, HEMI-FEMORAL, METAL

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION OFFICE CRYOABLATION SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·Sprint Quattro Lead

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella 5.0/LD