4,998 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ARCHITECT HBSAG QUALITATIVE/ ARCHITECT HBSAG QUALITATIVE CONFIRMATORY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ARCHITECT HBSAG QUALITATIVE/ ARCHITECT HBSAG QUALITATIVE CONFIRMATORY
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories
Dorsal Root Ganglion Stimulator For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generators (IPGs), leads, extensions, and accessories
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Spinal Cord Stimulation (SCS) System
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Infinity Deep Brain Stimulation (DBS) System
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·Angio-Seal Vascular Closure Devices
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ARCHITECT HBSAG/ARCHITECT HBSAG CONFIRMATORY/ARCHITECT I1000SR SYSTEM
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·ABBOTT MEDICAL OPTICS (AMO) HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·CORAB-M
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·Angio Seal Vascular Closure Device
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·Angio-Seal Vascular Closure Devices
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Fortify, Fortify Assura, and Ellipse
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Assurity MRI and Endurity MRI
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex µ, Quartet, and Quartet CRT Leads
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·Allure, Allure Quadra, and Quadra Allure MP
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Spinal Cord Stimulation (SCS) System