130 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
FDA Pre-Market Approval
FDA Class 3
·Infuse Bone Graft/Medtronic Interbody Fusion Device
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
FDA Pre-Market Approval
FDA Class 3
·Infuse Bone Graft
Bone Grafting Material, Dental, With Biologic Component
FDA Pre-Market Approval
FDA Class 3
·Infuse Bone Graft
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 Inflatable Penile Prosthesis and AMS 700 Inflatable Penile Prosthesis with InhibiZone Treatment
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 Artificial Urinary Sphincter and AMS 800 Artificial Urinary Sphincter with InhibiZone Treatment
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 Urinary Control System with and without Inhibizone
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 Series Product Line/Artificial Urinary Sphincter with and without InhibiZone Treatment
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 Inflatable Penile Prosthesis (IPP
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 Artificial Urinary Sphincter (AUS)
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·AMO SENSAR SOFT ACRYLIC MONOFOCAL INTRAOCULAR LENSES (IOLS)
Bone Grafting Material, Dental, With Biologic Component
FDA Pre-Market Approval
FDA Class 3
·GEM 21S
Bone Grafting Material, Dental, With Biologic Component
FDA Pre-Market Approval
FDA Class 3
·GEM 21S GROWTH FACTOR ENHANCED MATRIX
Laparoscopic Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·Falope-Ring Band Contraceptive Tubal Occlusion System
Programmer, Pacemaker
FDA Pre-Market Approval
FDA Class 3
·INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE
Laparoscopic Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·ADIANA PERMANENT CONTRACEPTION SYSTEM
Programmer, Pacemaker
FDA Pre-Market Approval
FDA Class 3
·MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE
Laparoscopic Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM