152 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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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
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
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 assays
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
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
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
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
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Restore, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems, Pisces, Specify®, and Vectris® Spinal Cord St
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim® Therapy System, Verify® Evaluation System
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim® Therapy System, Verify® Evaluation System
System, Test, Her-2/Neu, Nucleic Acid Or Serum
FDA Pre-Market Approval
FDA Class 3
·PATH VYSION HER-2 DNA PROBE KIT
Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence
FDA Pre-Market Approval
FDA Class 3
·URO VYSION BLADDER CANCER KIT
System, Test, Her-2/Neu, Nucleic Acid Or Serum
FDA Pre-Market Approval
FDA Class 3
·PATHVYSION HER-2 DNA PROBE KIT
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH
Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
FDA Pre-Market Approval
FDA Class 3
·VYSIS ALK BREAK APART FISH PROBE KIT AND PROBECHEK ALK NEGATIVE CONTROL SLIDES
Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence
FDA Pre-Market Approval
FDA Class 3
·UROVYSION BLADDER CANCER KIT
Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence
FDA Pre-Market Approval
FDA Class 3
·UROVYSION BLADDER CANCER KIT
Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence
FDA Pre-Market Approval
FDA Class 3
·UROVYSION BLADDER CANCER KIT
Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence
FDA Pre-Market Approval
FDA Class 3
·UroVysion Bladder Cancer Kit