569 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Immunohistochemistry Assay, Antibody, Ki-67
FDA Pre-Market Approval
FDA Class 3
·Ki-67 IHC pharmDx
Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
FDA Pre-Market Approval
FDA Class 3
·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·THE CLOSER AK 6 FR. SMC DEVICE
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·APTIMA HPV ASSAY
System, Test, Her-2/Neu, Ihc
FDA Pre-Market Approval
FDA Class 3
·PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
System, Test, Her-2/Neu, Ihc
FDA Pre-Market Approval
FDA Class 3
·PATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC.KAPPA 400 SERIES PACEMAKERS
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE