10,000 results · 25ms · Sources: EU EUDAMED, US FDA

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Gore CardioForm Septal Occluder

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·BD PrepMate

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·FRONTIER AND FRONTIER II FAMILIES OF PACEMAKERS

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN ABILITY LV LEAD

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·INFUSE BONE GRAFT

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·VNS THERAPY SYSTEM

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE 2 (HC2) HIGH RISK HPV DNA TEST

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·Prometra Programmable Infusion Pump System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Eureka!™ Monthly (samfilcon A) Contact Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BAUSCH & LOMB SOFLENS TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENSES

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·Epic Vascular Self-Expanding Stent System

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·COMBI 40+ Cochlear Implant System

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Nucleus ABI541 Auditory Brainstem Implant

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800 Artificial Urinary Sphincter (with and without InhibiZone); AMS 700 Inflatable Penile Prosthesis (with and witho

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·NAVISTAR CATHETER, INTERFACE CABLES

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·NOVATION CERAMIC AHS

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM