9,107 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·PROTEGO SD 60/16,PROTEGO SD 65/16,PROTEGO SD 75/18,PROTEGO S 60,PROTEGO S 65,PROTEGO S 75,PROTEGO T 65,PROTEGO TD 65/16,
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
FDA Pre-Market Approval
FDA Class 3
·INFUSE BONE GRAFT/LT CAGE LUMBAR TAPERED FUSION DEVICE
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·PROMUS Element Plus Everolimus-Eluting Stent System/PROMUS PREMIER Eeverolimus-Eluting Platinum Chromium Coronary Stent
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus Elite Everolimus-Eluting Platinum C
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·INTRAOCULAR LENS
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·AFFINITY/INTERNITY/VICTORY FAMILY OF PACEMAKERS
Agent, Absorbable Hemostatic, Non-Collagen Based
FDA Pre-Market Approval
FDA Class 3
·SURGICEL® Absorbable Hemostats (SURGICEL® ORIGINAL, SURGICEL® NU-KNIT , SURGICEL® FIBRILLAR, SURGICEL® SNOW)
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim Therapy System, Verify Evaluation System
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RADIESSE INJECTABLE IMPLANT
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·SCS NEUROSTIMULATORS IMPLANTABLE ITREL, RESORE AND SYNERGY FAMILIES,
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·NEXGEN LPS-FLEX MOBILE AND LPS BEARING KNEES
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·MYNXGRIP VASCULAR CLOSURE DEVICE
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·AGENT Paclitaxel-Coated Balloon Catheter
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE
Device, Thermal Ablation, Endometrial
FDA Pre-Market Approval
FDA Class 3
·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·CYPHER SIROLIMUS-ELUTING CORONARY STENT
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·LUMOS & TACHOS & BELOS FAMILY OF ICDS & XELOS DR-T
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·VISTAKON (ETAFILCON A) CONTACT LENSES