93 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TESTS
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·DML 3000 Microplate Luminometer, 5000-00031, digene® HC2 High-Risk HPV DNA Test (I plate), 5199-1220, digene® HC2 High-R
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS ANTI-HBC
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS ANTI-HBC IGM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS ANTI-HBE
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS ANTI-HBS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·HeartStart FRx Defibrillator
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·HeartStart FRx Defibrillator
Over-The-Counter Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·M5071A HS1 Adult SMART Pads Cartridge, M5072A HS1 Infant/Child SMART Pads Cartridge
Over-The-Counter Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·HeartStart OnSite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P
Over-The-Counter Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·HeartStart Onsite Defibrillator (M5066A), HeartStart Home Defibrillator (M5068A),HeartStart HS1 SMART Pads, Adult (M5071
Over-The-Counter Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·HeartStart Home Defibrillator (M5068A) and HeartStart Onsite Defibrillator (M5066A)
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·HeartStart FRx Defibrillator
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·HeartStart FRx Defibrillator
Over-The-Counter Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·HeartStart OnSite Defibrillator and HeartStart Home Defibrillator
Over-The-Counter Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·HeartStart OnSite Defibrillator and HeartStart Home Defibrillator
Over-The-Counter Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)