1,032 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·DERMAGRAFT-TC(TM)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys Anti-HBe, PreciControl Anti-HBe
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BIOFINITY (COMFILCON A)
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·MENICON Z RIGID GAS PERMEABLE CONTACT LENS
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·CONTINUOUS GLUCOSE MONITORING SYSTEM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR ANTI-HBS (AHBS)
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR ANTI-HBS (AHBS)
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·PD-L1 IHC 28-8 pharmDx
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·CERVISTA HPV 16/18
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·BIO-RAD MONOLISA ANTI-HBC EIA
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·CERVISTA HPV HR HIGH-THROUGHPUT AUTOMATION
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·PD-L1 IHC 28-8 pharmDx
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·BIO RAD MONOLISA ANTI-HBC IGM EIA
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·SOFLENS (POLYMACON) CONTACT LENSES
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·BIO-RAD MONOLISA ANTI-HBS EIA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG