267 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Lens, Multifocal Intraocular
FDA Pre-Market Approval
FDA Class 3
·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·AcrySof Posterior Chamber Intraocular Lens and Delivery Systems
Intracranial Aneurysm Flow Diverter
FDA Pre-Market Approval
FDA Class 3
·PIPELINE EMBOLIZATION DEVICE
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System, Impella RP with SmartAssist System
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5 System, Impella CP System, Impella CP with SmartAssist System, Impella 5.0 System, Impella LD System,Impella
FIRST MEDIC MODE 610
FDA 510(k)
FDA Class 3
·Cardiovascular
HEARTSTART 2000
FDA 510(k)
FDA Class 3
·Cardiovascular
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·NEW JERSEY LCS(R) TOTAL KNEE SYSTEM-ADDITION OF THREE PEGGED PATTELLA PROSTHESES
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·NG3 Implantable Cardioverter Defibrillators - Origen, Inogen, Dynagen, Autogen / NG4 - Momentum, Vigilant, Resonate, Per
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·NEW JERSEY LCS(R) TOTAL KNEE SYSTEM-ADDITION OF THREE PEGGED PATTELLA PROSTHESES
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·NEW JERSEY LCS(R) TOTAL KNEE SYSTEM-ADDITION OF THREE PEGGED PATTELLA PROSTHESES
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon, IN.PACT 018 Paclitaxel-Coated Per
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·Carpentier-Edwards PERIMOUNT/PERIMOUNT RSR/Magna Pericardial Aortic Bioprosthesis; Carpentir-Edwards PERIMOUNT Theon/PER
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis 3000, with ThermaFix tissue process 3000TFX,Ease Per
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
FDA Pre-Market Approval
FDA Class 3
·Nucleus® Hybrid L24 Cochlear Implant System
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
FDA Pre-Market Approval
FDA Class 3
·PROSTATRON
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
FDA Pre-Market Approval
FDA Class 3
·UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
FDA Pre-Market Approval
FDA Class 3
·PROLIEVE THERMODILITATION SYSTEM
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
FDA Pre-Market Approval
FDA Class 3
·UROLOGIX TARGIS SYSTEM FOT THE TREATMENT OF BPH