20 results · 19ms · Sources: EU EUDAMED, US FDA

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMAX FAMILY OF ICDS AND CRT-DS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SYNCHROMED INFUSION SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS TOTAL KNEE SYSTEM - ADDITION OF POSTERIOR STABILIZED FEMORAL AND BEARING COMPONENTS & RPII TIBIAL TRAYS & BEARING CO

Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA Pre-Market Approval
FDA Class 3 ·LCS(R)TOTAL KNEE SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·INCEPTA, ENERGEN AND PUNTUA IDCS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·INCEPTA, ENERGEN AND PUNTUA IDCS

Device, Dermal Replacement

FDA Pre-Market Approval
FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE - TERMINALLY STERILIZED (IDRT-TS)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MARQUIS IDC FAMILY, MAXIMO ICD FAMILY, INTRINSIC ICD FAMILY, ENTRUST ICD FAMILY

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·KRONOS LV-T CRT-D & LUMAX VR/DR/HF (-T) ICDS & CDT-DS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·ASCENDA INTRATHECAL CATHETER WITH 86 CM SPINAL SEGMENT, 66CM SPINAL SEGMENT, 86 CM SPINAL SEGMENT REVISION KIT, ACCESSOR

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval
FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval
FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval
FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval
FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval
FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval
FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·TVL(TM) LEAD SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EVERA MRI DF-1 ICD, EVERA MRI IDC, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, VISIA AF MRI DF1 IC

S80 IMPLANTABLE CARDIAC PACING LEAD

FDA 510(k)
FDA Class 3 ·Cardiovascular