9,107 results · 30ms · Sources: EU EUDAMED, US FDA

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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