371 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS TOTAL KNEE SYSTEM
Implant, Hearing, Active, Middle Ear, Partially Implanted
FDA Pre-Market Approval
FDA Class 3
·VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM
Prosthesis, Spinous Process Spacer/Plate
FDA Pre-Market Approval
FDA Class 3
·COFLEX® INTERLAMINAR TECHNOLOGY
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·EVIA/ENTOVIS & VARIOUS MODELS OF PHILOS/PHILOS2 & CYLOS PULSE GENERATORS; SELOX JT/ST/SR, DEXTRUS, SELTROX S, SLX
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·KAINOX VCS, LINOX S/T/SD/TD, KENTROX SL-S/RV-S/SL/RV STEROID, LINOX(SMART) ST/TD LEADS
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·VARIOUS MODELS OF LUMAX ICD/CRT-D FAMILIES; COROX OTW UP STEROID LEAD
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·LEXOS DR/DR-T/VR/VR-T AND LUMOS DR-T/VR-T ICDS
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
FDA Pre-Market Approval
FDA Class 3
·UROWAVE
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·CentriMag Circulatory Support System
Microspheres Radionuclide
FDA Pre-Market Approval
FDA Class 3
·SIR-Spheres microspheres
Light Source System, Diagnostic Endoscopic
FDA Pre-Market Approval
FDA Class 3
·KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM
Stimulator, Low Electric Field, Tumor Treatment
FDA Pre-Market Approval
FDA Class 3
·NOVOTTF-100A SYSTEM
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·CERAMAX Ceramic Total Hip System
Stimulator, Low Electric Field, Tumor Treatment
FDA Pre-Market Approval
FDA Class 3
·Optune System
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS SAPIEN TRANSCATHER HEART VALVE
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS SAPIEN TRANSCATHETER HEART VALVE
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE; EDWARDS QUALCRIMP CRIMPING ACCESSORY
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS Total Knee System
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS, THEON PERICARDIAL AOTIC BIOPROSTHESIS WITH THERMAFIX TISSUE PROCESS
Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
FDA Pre-Market Approval
FDA Class 3
·TRUFILL n-Butyl Cyanoacrylate (n-BCA)Liquid Embolic System