138 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ANGIOJET ULTRA XMI THROMBECTOMY SET,ANGIOJET ULTRA SPIROFLEX THROMBECTOMY SET,ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY
Barrier, Absorbable, Adhesion
FDA Pre-Market Approval
FDA Class 3
·ADEPT Adhesion Reduction Solution
Transcatheter Septal Occluder (Atrial)
FDA Pre-Market Approval
FDA Class 3
·Occlutech ASD Occluder, Occlutech Pistol Pusher (OPP), Occlutech ASD Occluder Procedure Pack
Transcatheter Septal Occluder (Atrial)
FDA Pre-Market Approval
FDA Class 3
·Occlutech® ASD Occluder and Occlutech® Pistol Pusher
Transcatheter Septal Occluder (Atrial)
FDA Pre-Market Approval
FDA Class 3
·Occlutech® ASD Occluder and Occlutech® Pistol Pusher
Intravascular Radiation Delivery System
FDA Pre-Market Approval
FDA Class 3
·NOVOSTE BETA-CATH SYSTEM
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 2000+ BONE HEALING SYSTEM
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·DERMAGRAFT
Stent, Renal
FDA Pre-Market Approval
FDA Class 3
·Express SD Renal
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·POSTERIOR CHAMBER IOL
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·Ranger Paclitaxel-Coated PTA Balloon Catheter
Stent, Renal
FDA Pre-Market Approval
FDA Class 3
·EXPRESS SD RENAL PREMOUNTED STENT SYSTEM
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·REBEL MONORAIL AND OVER THE WIRE PLATINUM CHROMIUM CORONARY STENT SYSTEM
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
FDA Pre-Market Approval
FDA Class 3
·Plasmaflo OP-05W(A)
Organ Care System (Ocs) Heart System
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS) Heart
Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS) Lung
Barrier, Absorbable, Adhesion
FDA Pre-Market Approval
FDA Class 3
·ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN)
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS) Liver
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HeartWare® HVAD System
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·STEROX S AND DEXTRUS FAMILY OF IMPLANTABLE PACEMAKER PULSE GENERATORS AND PROGRAMMERS