10,000 results
·
244ms
·
Sources: EU EUDAMED, US FDA
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·DuraSeal Dural Sealant System
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·DuraSeal Exact System
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·CraniSeal Dural Sealant
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·VIVA QUAD XT CRT-D,VIVA QUAD S CRT-D,BRAVA QUAD CRT-D,VIVA QUAD C CRT-D,VIVA/BRAVA/EVERA SOFTWARE APPLICATION
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·CARELINK MONITOR,CARDIOSIGHT READER,CARELINK EXPRESS,DEVICE DATA MANAGEMENT APPLICATION(DDMA)
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ZENITH AAA ENDOVASCULAR GRAFT
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·QUICKSEAL CONTROL ARTERIAL CLOSURE SYSTEM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBS,ELECSYS PRECICONTROL ANTI-HBS
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Senza Spinal Cord Stimulation (SCS) System
Aortic Stent
FDA Pre-Market Approval
FDA Class 3
·Minima Stent System
Extended Depth Of Focus Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·AcrySof IQ Vivity Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·GUARDIAN REAL-TIME AND PARADIGM REAL-TIME SYSTEMS
Intracranial Aneurysm Flow Diverter
FDA Pre-Market Approval
FDA Class 3
·Pipeline Vantage Embolization Device with Shield Technology (Pipeline Vantage)
Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay
FDA Pre-Market Approval
FDA Class 3
·VENTANA MMR RxDx Panel
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·Nucleus 24 Cochlear Implant System
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System, DISCOVISC Ophthalmic Viscosurgical
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS TOTAL KNEE SYSTEM
Enzyme Immunoassay, Cannabinoids
FDA Pre-Market Approval
FDA Class 2
·DR. BROWN'S HOME DRUG TESTING KIT
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·PROVSIC Ophthalmic Viscosurgical Device