82 results · 20ms · Sources: EU EUDAMED, US FDA

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval
FDA Class 3 ·VENTANA ALK (D5F3)

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 HER2 Dual ISH DNA Probe Cocktail

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-C-KIT

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·SOFT ACRYLIC INTRAOCULAR LENSES (IOLS)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFT ACRYLIC INTRAOCULAR LENSES (IOLS)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFT ACRYLIC INTRAOCULAR LENSES (IOLS)

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS Total Knee System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·LATITUDE™ NXT Remote Patient Management System, LATITUDE™Wave Communicator, LATITUDE™ Consult Communicator, LATITUDE™ NX

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval
FDA Class 3 ·i-FACTOR Peptide Enhanced Bone Graft

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·Straumann Emdogain

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·EMDOGAIN GEL

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·EMDOGAIN

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval
FDA Class 3 ·AUGMENT BONE GRAFT

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval
FDA Class 3 ·AUGMENT Bone Graft and AUGMENT Injectable

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·STRAUMANN EMDOGAIN

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·Staumann Emdogain

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval
FDA Class 3 ·I-FACTOR PEPTIDE ENHANCED BONE GRAFT

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval
FDA Class 3 ·DAKOCYTOMATION EGFR PHARMDX

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·Straumann Emdogain