50 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Cap, Cervical, Contraceptive
FDA Pre-Market Approval
FDA Class 3
·FEMCAP
BIOTRONIK DN UNIPOLAR PE-60/4-DN &
FDA 510(k)
FDA Class 3
·Cardiovascular
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC KAPPA 900/800 SERIES PACING SYSTEM
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·TACHOS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·THERASCREEN EGFR RGQ PCR KIT
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·THERASCREEN KRAS RGQ PCR KIT
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
FDA Pre-Market Approval
FDA Class 3
·Lacrosse NSE ALPHA Coronary Dilatation Catheter
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
FDA Pre-Market Approval
FDA Class 3
·Lacrosse NSE ALPHA Coronary Dilatation Catheter
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KON
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KON
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KON
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·C-flex Intraocular Lens, C-flex Aspheric Intraocular Lens, 6.0mm Aspheric Intraocular Lens adn RayOne Aspheric
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Master Restore, Itrel and Intellis Spinal Cord Stimulation Systems adn Pisces, Specify, and Vectris Spinal COrd Stimulat
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Spinal Cord Stimulation Leads; Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems adn Pisces, S
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Restore, Itrel, Synergy and Intellis Sprinal Cord Stimulation Systems and Pisces, Specify,adn Vectris Sprinal Cord Stimu
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Restore, Itrel, Synergy and Intellis Sprinal Cord Stimulation Systems and Pisces, Specify,adn Vectris Sprinal Cord Stimu
MODEL 366-09 ADAPTAID ADAPTER SLEEVE
FDA 510(k)
FDA Class 3
·Cardiovascular
MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE
FDA 510(k)
FDA Class 3
·Cardiovascular
MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE
FDA 510(k)
FDA Class 3
·Cardiovascular