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Nombre Clasificación Fabricante Nivel de riesgo País Fuente
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT Axis-Shield Diagnostics Limited Spain AEMPSVFOI
Kit for determination of C-reactive protein Afinion CRP Axis-Shield PoC AS Spain AEMPSVFOI
Afinion AS100 analyzers, and Afinion CRP and Afinion CRP control Axis-Shield PoC AS Spain AEMPSVFOI
Reformulated product: Kit for the determination of C-reactive protein Afinion ™ CRP (C-Reactive Protein), Ref .: 1115907 (which will replace the previous reference 1115013) Axis-Shield PoC AS Spain AEMPSVFOI
Dengue Kit IgM Capture ELISA from Panbio Inverness Medical Innovations Australia Pty Ltd/Alere Spain AEMPSVFOI
Lot 110925 of the kit "Immunocomb® II Rubella IgG", catalog number 60400002, manufactured by Orgenics Ltd, Israel. Orgenics Ltd Spain AEMPSVFOI
Implantable pulse generators Brio ™ St. Jude Medical Spain AEMPSVFOI
"NanostimTM Wireless Pacemaker & Placement System Catheter", model S1DLCP St. Jude Medical Spain AEMPSVFOI
"Portico ™ Transcatheter Transcatheter Transcatheter Valve Transfemoral Implantation System" St. Jude Medical Spain AEMPSVFOI
"Portico ™ transcatheter transcatheter transcatheter aortic valve implantation system", models PRT-23 and PRT-25 St. Jude Medical Spain AEMPSVFOI
Defibrillators (ICDs) and implantable pacemakers with radiofrequency (RF) capability St. Jude Medical Spain AEMPSVFOI
Fortified ™ Implantable Cardioverter Defibrillators, FortifyAssura ™, QuadraAssura ™, QuadraAssura MP ™, Unify ™, UnifyAssura ™ and UnifyQuadra ™ St. Jude Medical Spain AEMPSVFOI
NanostimTM wireless cardiac pacemaker, model S1DLCP N/A Spain AEMPSVFOI
NanostimTM wireless cardiac pacemaker, model S1DLCP and "Nanostim Programmer Link" St. Jude Medical Spain AEMPSVFOI
Merlin @ Home ™ Model EX2000 Software for the Merlin @ Home ™ Transmitter, EX1150, EX1150W, EX1100, and EX1100W St. Jude Medical Spain AEMPSVFOI
Implantable Automatic Defibrillators (DAIs) EllipseTM VR / DR, models CD1411-36Q, CD1411-36C, CD2411-36Q, CD2411-36C, CD1377-36QC, CD1377-36C, CD2377-36QC and CD2377-36C St. Jude Medical CRMD Spain AEMPSVFOI
"Left Ventricular Electrodes for QuickSite® CRT", Models 1056T and 1058T and "Left Ventricular Electrodes for QuickFlex® TRC", Models 1156T and 1158T manufactured by St. Jude Medical CRMD, USA. St. Jude Medical CRMD Spain AEMPSVFOI
Implantable pulse generators: "Eon", Model 65-3716 and "Eon Mini", Model 65-3788 for stimulation of the spinal cord and "Brio", Model 65-6788 for deep brain stimulation, manufactured by St. Jude Medical USA St. Jude Medical Spain AEMPSVFOI
Implantable pulse generators: "Eon MiniTM", Model 65-3788 for stimulation of the spinal cord and "BrioTM", Model 65-6788 for deep brain stimulation. Serial numbers manufactured before September 2010 by St. Jude Medical USA St. Jude Medical Spain AEMPSVFOI
Implantable Pulse Generator (GPI) "Eon MiniTM" Model 65-3788 for stimulation of the spinal cord, Eon Min Model 3721 Charger and Eon Mini Model 3719 Charger Accessory, manufactured by St. Jude Medical USA St. Jude Medical Spain AEMPSVFOI
Fortified ™ Implantable Cardioverter Defibrillators, FortifyAssura ™, QuadraAssura ™, QuadraAssura MP ™, Unify ™, UnifyAssura ™ and UnifyQuadra ™, manufactured by St. Jude Medical, USA, between January 2010 and May 2015. St. Jude Medical Spain AEMPSVFOI
"Panbio Q Fever IgM ELISA", catalog number 06PE20, lot 264006 Standard Diagnostics Inc. Spain AEMPSVFOI
Kit Panbio Leptospira IgM Elisa Standard Diagnostics, Inc. Spain AEMPSVFOI
HeartMate II LVAS system Cardiovascular Devices Thoratec Corporation Spain AEMPSVFOI
All serial numbers of the "HeartMate II Left Ventricular Assist System Implant Kit with grafts", Model 104912, manufactured by Thoratec Corporation, USA. Cardiovascular Devices Thoratec Corporation Spain AEMPSVFOI