43 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS Toric II 1-Piece IOLs, TECNIS Symfony Toric II Extended Range of Vision IOLs
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS Multifocal Toric II Intraocular Lenses
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM
Barrier, Absorbable, Adhesion
FDA Pre-Market Approval
FDA Class 3
·INTERCEED ABSORBABLE ADHESION BARRIER
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·Arctic Front Advance Cardiac Cryoablation Catheters
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC MODEL 7219B, 7219E, AND 7202E ARRYTHMIA MANAGEMENT DEVICES.
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·9600CR Crimper
Stimulator, Low Electric Field, Tumor Treatment
FDA Pre-Market Approval
FDA Class 3
·Optune System
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·FreeStyle Libre Pro Flash Glucose Monitoring System
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Edwards SAPIEN 3 Transcatheter Heart Valve
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Edwards SAPIEN XT Transcatheter Heart Valve
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Internal Leads Extensions and 8 Chanel Adapters
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Paddle Leads
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces Specify and Vectris Spinal Cord S
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·SynchroMed Infusion System Ascenda Intrathecal Catheters
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA Pre-Market Approval
FDA Class 3
·InterStim Therapy System. Verify Evaluation System
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Activa Deep Brain Stimulation Therapy System