2,328 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS TOTAL KNEE SYSTEM
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HeartWare® Ventricular Assist System, HeartWare® System
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ANCURE ENDOGRAFT SYSTEM/ANCURE ILIAC BALLOON CATHETER
Drug-Eluting Sinus Stent
FDA Pre-Market Approval
FDA Class 3
·Propel, Propel Mini and Propel Contour Sinus Implants
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Trifecta Valve and Trifecta Valve with Glide Technology (Trifecta GT)
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·NG3 DEVICES: ORIGEN , INOGEN, &, DYNAGEN CRT-D; PROGENGY DEVICES: PUNCTUA , ENERGEN , & INCEPTA CRT-D'S
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Lead EV ICD Extravascular - Epsila
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·TRIPOLE 16 & 16C LEADS, EXCLAIM LEADS, LAMITRODE 4, LAMITRODE 44 & LAMITRODE 44C LEADS, LAMITRODE 88 LEAD, LAMITRODE S-4
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·L100 ESSENTIO SR, L101 ESSENTIO DR, L121 ESSENTIO EL DR, L200 PROPONENT SR, L201 PROPONENT DR, L221 PROPONENT EL D
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ENDOTAK LEAD SYSTEM
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·BLAZER II TEMPERATURE ABLATION CATHETER, BLAZER II HTD TEMPERATURE ABLATION CATHETER
Shunt, Portosystemic, Endoprosthesis
FDA Pre-Market Approval
FDA Class 3
·WALLSTENT(R) TIPS ENDOPROSTHESIS AND UNISTEP(TM) PLUS DELIVERY SYSTEM
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·Alinity m HBV Assay
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·Relay Thoracic Stent-Graft with Plus Delivery System
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·U125 VALITUDE CRT-P, U128 VALITUDE X4 CRT-P, U225 VISIONIST CRT-P, U226 VISIONIST CRT-P, U228 VISIONIST X4 CRT-P
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·PUNCTUA ICDS,TELIGEN ICDS,ENERGEN ICDS,INCEPTA ICDS,ORIGEN ICDS,INOGEN ICDS,DYNAGEN ICDS
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·EXPRESS2 CORONARY STENT SYSTEM