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Sources: EU EUDAMED, US FDA
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Classification: FDA Class 3
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System, Photopheresis, Extracorporeal
FDA Pre-Market Approval
FDA Class 3
·THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHERESIS PROCEDURAL KIT (125ML) THERAKOS CELLEX LIGHT ASSEMBLY
System, Photopheresis, Extracorporeal
FDA Pre-Market Approval
FDA Class 3
·THERAKOS CELLEX PHOTOPHERESIS SYSTEM
System, Photopheresis, Extracorporeal
FDA Pre-Market Approval
FDA Class 3
·THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·X Series, R Series, Propaq MD, and AED Pro
System, Photopheresis, Extracorporeal
FDA Pre-Market Approval
FDA Class 3
·UVAR PHOTOPHERESIS SYSTEM
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Pedi-padz Multifunction Electrodes, Pro-padz Cardiology W/LVP Gel Electrodes, Pro-padz Radiolucent Liquid Gel Electrodes
System, Photopheresis, Extracorporeal
FDA Pre-Market Approval
FDA Class 3
·UVAR PHOTOPHERESIS SYSTEM
System, Photopheresis, Extracorporeal
FDA Pre-Market Approval
FDA Class 3
·UVAR XTS PHOTOPHORESIS SYSTEM
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·X Series/Propaq MD
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·AED Plus
System, Photopheresis, Extracorporeal
FDA Pre-Market Approval
FDA Class 3
·THERAKOS UVAR XTS Photopheresis System Procedural Kit
System, Photopheresis, Extracorporeal
FDA Pre-Market Approval
FDA Class 3
·UVAR XTS PHOTOPHERESIS SYSTEM
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·ZOLL AED 3 and ZOLL AED 3 Automatic
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER; ETHICON ENDO-SURGERY GASTRIC BAND SUTUR
System, Photopheresis, Extracorporeal
FDA Pre-Market Approval
FDA Class 3
·THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAKO
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Zoll OneStep Cable, X Series Multifunction Therapy Cable, Propaq MD Multifunction Cable, X Series OneStep Cable, Multifu
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·AED 3 BLS
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·MFC-CPRD Cable Assembly used with X Series and R Series Device
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Zoll AED 3 and Zoll AED 3 Automatic