29 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
System, Laser, Transmyocardial Revascularization
FDA Pre-Market Approval
FDA Class 3
·TMR Holmium Laser System
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·Webster Electrophysiology Catheter, Celsius Electrophysiology Catheter, Electrophysiology Catheter Deflectable braided t
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Celsius ThermoCool Electrophysiology Catheter, Navistar RMT Thermocool and Celsius RMT THermocool
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Celsius DS Electrophysiology Catheter
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·Smartablate Cable
Absorbable Collagen Hemostatic Agent With Thrombin
FDA Pre-Market Approval
FDA Class 3
·VITAGEL RT3 SUTGICAL HEMOSTAT
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·Medtronic Open Pivot Heart Valve, Medtronic Open Pivot Aortic Valved Graft
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMBICOR INFLATABLE PENILE PROSTHESES
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·REGENT,STANDARD,MASTERS MECHANICAL HEART VALVES
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·INTERSTIM
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·THORATEC HEARTMATE II LVAS
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·INTERSTIM
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·RESTORE, ITREL, SYNERGY
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·ACTIVA, SOLETRA, KINETRA
Transcatheter Septal Occluder
FDA Pre-Market Approval
FDA Class 3
·AMPLATZER MUSCULAR VSD OCCLUDER
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Aveir Leadless System (Dual-Chamber)
Leadless Pacemaker
FDA Pre-Market Approval
FDA Class 3
·Aveir Leadless System (Dual-Chamber)
Occluder, Patent Ductus, Arteriosus
FDA Pre-Market Approval
FDA Class 3
·SEPTAL OCCLUDER AND MULTIFENESTRATED SEPTAL (CRIBRIFORM) OCCLUDER
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Aveir Leadless System (Dual-Chamber)