2,856 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·Bellafill Dermal Filler
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODELS 019B, 019C, 019E, 019F, 019J, & 019K
System, Test, Her-2/Neu, Ihc
FDA Pre-Market Approval
FDA Class 3
·PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Avalus Bioprosthesis
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
Artificial Heart
FDA Pre-Market Approval
FDA Class 3
·Syncardia Temporary Cardio West Total Artificial Heart (TAH-T)
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·HANCOCK BIOPROSTHESIS MODELS 242,342,343C,342R
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·Bellafill Dermal Filler
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODELS 019B, 019C, 019E, 019F, 019J, & 019K
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
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, Test, Her-2/Neu, Ihc
FDA Pre-Market Approval
FDA Class 3
·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
Artificial Heart
FDA Pre-Market Approval
FDA Class 3
·SynCardia temporary Total Artificial Heart (TAH-t) System
Immunohistochemistry Antibody Assay, C-Kit
FDA Pre-Market Approval
FDA Class 3
·PATHWAY Anti-c-KIT (9.7) Primary Antibody
System, Test, Her-2/Neu, Ihc
FDA Pre-Market Approval
FDA Class 3
·PATHWAY ANTI-HER -2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
FDA Pre-Market Approval
FDA Class 3
·INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL