2,328 results · 16ms · Sources: EU EUDAMED, US FDA

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