134 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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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
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·Adherus AutoSpray Dural Sealant, Adherus ET Autospray Dural Sealant
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·(MBX, MHY, NHL, PJS) -Master Percept and Activa Deep Brain Stimulation Therapy Systems
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·LATITUDE NXT Remote Patient Management System, LATITUDEWave Communicator, LATITUDE Consult Communicator, LATITUDE NX
Filler, Bone Void, Synthetic Peptide
FDA Pre-Market Approval
FDA Class 3
·i-FACTOR Peptide Enhanced Bone Graft
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·Vercise Deep Brain Stimulation (DBS) System, Vercise PC Deep Brain Stimulation (DBS) System, and Vercise Gevia Deep Brai
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·Implantable Pluse Generator (IPG): Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·Vercise PC, Vercise Gevia, Vercise Genus Deep Brain Stimlation (DBS) Systems
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System
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
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) Systems
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·Vercise Genus Deep Brain Stimulation (DBS) System
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
FDA Pre-Market Approval
FDA Class 3
·Vercise Deep Brain Stimulation (DBS)System
Filler, Bone Void, Synthetic Peptide
FDA Pre-Market Approval
FDA Class 3
·I-FACTOR PEPTIDE ENHANCED BONE GRAFT