3,616 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions
FDA Pre-Market Approval
FDA Class 3
·GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
FDA Pre-Market Approval
FDA Class 3
·XVIVO Perfusion System (XPS) with STEEN Solution Perfusate
Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
FDA Pre-Market Approval
FDA Class 3
·TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
FDA Pre-Market Approval
FDA Class 3
·XVIVO Perfusion System with STEEN Solution Perfusate
Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
FDA Pre-Market Approval
FDA Class 3
·TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
FDA Pre-Market Approval
FDA Class 3
·TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
FDA Pre-Market Approval
FDA Class 3
·TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM.
Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions
FDA Pre-Market Approval
FDA Class 3
·GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE)
Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
FDA Pre-Market Approval
FDA Class 3
·TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne Liquid CDx (F1 Liquid CDx)
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne Liquid CDx
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MARQUIS/MAXIMO& MAXIMO II IPG/INTRINSIC/ENTRUST/VIRTUOSO II DR/VR/ONYX/VIRTUOSO FAMILY OF ICDS/SECURA ICD
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS 1-Piece Multifocal IOLs; TECNIS Symfony Extended Range of Vision (EVR) IOL., TECNIS Symfony Toric ERV IOLs
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS Toric II 1-Piece Intraocular Lenses and TECNIS Symfony Toric II Extended Range of Vision Introacular Lensses
Pulse-Generator, Single Chamber, Sensor Driven, Implantable
FDA Pre-Market Approval
FDA Class 3
·MICRONY FAMILY OF PACEMAKERS PACEMAKER PROGRAMMER MODEL 3330 VERSION 5.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·KAPPA 600/700/650/800/900/SIGMA/MEDTRONIC 350 IPG/ENPULSE/ADAPTA/VERSIA/SENSIA/RELIA FAMILIES OF IPG
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·PROMOTE, PROMOTE ACCEL,PROMOTE Q, PROMOTE QUADRA,PROMOTE+,QUADRA ASSURA,UNIFY,UNIFY QUADRA FAMILIES OF CRT-D DEVICES
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·Various models of single chamber ICDS in the Lumax, Ilesto, Iforia, Iperia, Itrevia, Inventra Families, Various models o
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·VARIOUS FAMILIES OF PACEMAKERS, REAL PLUS & BOSS REVEAL PLUS PREVA FAMILY, VITATRON VISA, VITATRON LEGACY FAMILY, THERA
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RADIESSE INJECTABLE IMPLANT FOR SUB-DERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FO