420 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF (GRAFTSKIN)
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·Implantable System for Remodulin
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
FDA Pre-Market Approval
FDA Class 3
·Birmingham Hip Resurfacing (BHR) System
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS(R) Total Knee System
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ICE ORIGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD INOGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD DYNAGE
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF (GRAFTSKIN)
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
FDA Pre-Market Approval
FDA Class 3
·Cormet Hip Resurfacing System
Stimulator, Autonomic Nerve, Implanted For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·VNS Therapy® SenTiva® Model 1000 Generator, VNS Therapy® AspireSR Model 106 Generator, VNS Therapy® Demipulse Model 103
Enzyme Immunoassay, Fetal Fibronectin
FDA Pre-Market Approval
FDA Class 3
·Rapid fFN for the TLiIQ System
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·enVista hydrophobic acrylic IOL, enVista toric hydrophobic acrylic IOL, enVista Aspire hydrophobic acrylic IOL, enVista
Stimulator, Autonomic Nerve, Implanted For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·SenTiva Model 1000 and SenTiva Duo Model 1000-D Generator Rhodium Reed Switch
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM
Inhibitor, Peridural Fibrosis (Adhesion Barrier)
FDA Pre-Market Approval
FDA Class 3
·ADCON -L ADHESION CONTROL IN A BARRIER GEL
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM
Fluid, Intraocular
FDA Pre-Market Approval
FDA Class 3
·SILIKON 1000
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
FDA Pre-Market Approval
FDA Class 3
·CORMET HIP RESURFACING SYSTEM
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·VISX EXCIMER LASER SYSTEM MODELS B AND C
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·NAVISTAR DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER AND CELSIUS DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER