2,579 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ACS:180/ADVIA CENTAUR AFP IMMUNOASSAY
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·LIFEPAK 20e defibrillator/monitor
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Powerheart G5 AED
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
Monitor, Intracranial Pressure, Implanted
FDA Pre-Market Approval
FDA Class 3
·ICP TELE-MONITOR & ICP TELE-SENSOR
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 INFLATABLE PENILE PROSTHESIS
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·COSMETIC TISSUE AUGMENTATION PRODUCT
Stent, Urethral, External Sphincter, Permanent
FDA Pre-Market Approval
FDA Class 3
·UROLUME ENDOPROSTHESIS
Laparoscopic Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·FALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·LIFEPAK Automated External Defibrillators (AEDs)
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·AutoDELFIA hAFP Test System
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·ORBERA Intragastric Balloon (IGB) System
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·HeartStart FRx Defibrillator (861304)
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·LIFEPAK 35 Monitor/Defibrillator, LIFEPAK FLEX Battery
Laparoscopic Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·ADIANA PERMANENT CONTRACEPTION SYSTEM
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·HeartStart FR3 Defibrillator
Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS) Lung
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 Artificial Urinary Sphincter