5,924 results
·
151ms
·
Sources: EU EUDAMED, US FDA
Alpha-1-Fetoprotein (AFP) - RP001, PDR013
FDA registration
DIAGNOSTIC BIOSYSTEMS·1 product·🇺🇸 United States
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·PD-L1 IHC 22C3 PharmDx
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·Oncomine Dx Target Test
Stimulator, Hypoglossal Nerve, Implanted, Apnea
FDA Pre-Market Approval
FDA Class 3
·Inspire II Upper Airway Stimulator
Lens, Contact (Rigid Gas Permeable), Extended Wear
FDA Pre-Market Approval
FDA Class 3
·BOSTON EQUEALENS RIGID GAS/II RIGID GAS PERMEABLE CONTACT LENS
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·Nucleus 24 Cochlear Implant System
Stimulator, Hypoglossal Nerve, Implanted, Apnea
FDA Pre-Market Approval
FDA Class 3
·Inspire Upper Airway Stimulation
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER
Assay, Genotyping, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·PD-L1 IHC 22C3 pharmDx
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·APTIMA HPV ASSAY
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·FRESHLOOK SPHERICAL, TORIC AND BIFOCAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR UP TO 7 DAYS/
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 HR AND GENFIND DNA EXTRACTION KIT
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·CERVISTA HPV 16/18
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·PD-L1 IHC 28-8 PHARMDX
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·HOME MONITORING SYSTEM
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·FRESHLOOK DIMENSIONS (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR UP TO 7 DAYS/6 NIGHTS (SPHERICAL
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·PD-L1 IHC 28-8 pharmDx