243 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·VALITUDE / VALITUDE X4 / VISIONIST / VISIONIST X4 / Accolade C ardiac Resynchronization Therapy-Pacemaker (CRT-P) Device
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ORIGEN / INOGEN / DYNAGEN /AUTOGEN /MOMENTUM /VIGILANT/ PERCIVA / RESONATE/ Implantable Cardioverter Defibrillator (ICD)
Stimulator, Autonomic Nerve, Implanted For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBsAg Next Qualitative I Qualitative Confirmatory/ Alinity i HBsAg Next Qualitative I Alinity i HBsAg Next Con
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·DYNAGEN MINI, INOGEN MINI, ORIGEN MINI and PERCIVA MINI
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·DYNAGEN EL ICD: D150, D151, D152, D153; INOGEN EL ICD: D140, D141, D142, D143; ORIGEN EL ICD: D050, D051, D052, D053;
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·lntera 3000 Hepatic Artery Infusion Pump
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·DYNAGEN CRT-D: G150, G151, G154; DYNAGEN X4 CRT-D: G156, G158; INOGEN CRT-D: G140, G141; INOGEN X4 CRT-D: G146, G148
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·CADENCE FAMILY OF ICDS
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·EPIC HF/ATLAS + HF FAMILY OF CRT-DS
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC MODEL 7221 B/C/CX/D/E MICRO JEWEL W/MODEL 5434 ACTIVE CAN EMULATOR AND MODEL 9894
Implanted Brain Stimulator For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·NeuroPace® RNS® System
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Atellica® IM Hepatitis B surface Antigen II (HBsll), Atellica® IM Hepatitis B surface Antigen 11 Confirmatory (HBsll Con
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·ITREL 3, SOLETRA, DCI (SYNERGY)
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·KAPPA 700, VITATRON, KAPPA 900, ENPULSE, SIGMA, MEDTRONIC 350 SERIES, ENRHYTHM
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·SYNERGY VERSITREL, KINETRA
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR SYSTEM
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MARQUIS DR, MARQUIS VR, MAXIMO DR, MAXIMO VR, INTRINSIC 30, INTRINSIC, ENTRUST 30J/35J
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC KAPPA 400 SERIES PACEMAKER SYSTEMS