10,000 results
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25ms
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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
·MODELS PC10 & PC21
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·DEFLUX INJECTABLE GEL
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·PERMLENS
Kit, Rna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·APTIMA HPV ASSAY
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARTENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·HIRESOLUTION BIONIC EAR SYSTEM
Lens, Intraocular, Phakic
FDA Pre-Market Approval
FDA Class 3
·VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·THORATEC VENTRICULAR ASSIST DEVICE SYSTEM
Pulse-Generator, Single Chamber, Sensor Driven, Implantable
FDA Pre-Market Approval
FDA Class 3
·MICRONY PACEMAKERS
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HEARTMATE XVE LVAS
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
·SAPIEN XT TRANSCATHETER HEART VALVE
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·Tendril ST 1888/1882 TC; Tendril STS 2088 TC; Optisense 1999
Automated Insulin Dosing Device System, Single Hormonal Control
FDA Pre-Market Approval
FDA Class 3
·MiniMed 670G Insulin Pump
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·Mosaic Bioprosthesis, Models 305 and 310
Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
FDA Pre-Market Approval
FDA Class 3
·Light Adjustable Lens (LAL), Light Delivery Device (LDD) System
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·ANTERIOR CHAMBER INTRAOCULAR LENS
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL Z9000
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·THERMOCOOL SMARTTOUCH SF Catheter