940 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT, MICROFIBRILLAR FORM
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING, CARPENTIER-EDWARDS DURAFLEX LOW
Device, Dermal Replacement
FDA Pre-Market Approval
FDA Class 3
·INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·CEEON EDGE AND TECNIS FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·CEEON PMMA UV-LIGHT ABSORBING POSTERIOR CHAMBER (IOLS)
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RHA® Redensity, RHA® 2, RHA® 3, RHA® 4
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Avalus Bioprosthesis and Avalus Ultra Bioprosthesis
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·CEEON HEPARIN SURFACE MODIFIED UV-LIGHT ABSORBING ANTERIOR CHAMBER (IOLS)
Automated Insulin Dosing Device System, Single Hormonal Control
FDA Pre-Market Approval
FDA Class 3
·Medtronic MiniMed 670G System, Medtronic MiniMed 770G System
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·SENSAR SOFT ACRYLIC UV LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·Medtronic MiniMed 630G System with SmartGuard
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·Resolute Onyx Zotarolimus-Eluting Coronary Stent System
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ANEURX AAADVANTAGE STONE GRAFT WITH XCELERANT DELIVERY SYSTEM
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·FRONTIER/FRONTIER II FAMILY OF CRT-PS
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·MECHANICAL HEART VALVE SJM(R) MASTER SERIES
Pulse-Generator, Single Chamber, Sensor Driven, Implantable
FDA Pre-Market Approval
FDA Class 3
·VARIOUS FAMILIES OF PACEMAKERS
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·LEGEND PLUS FAMILY OF PACEMAKERS
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter SPinal Cor