BEUDAMED
    384 results · 23ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·AMPLATZER MUSCULAR VSD OCCLUDER

    Occluder, Patent Ductus, Arteriosus

    FDA Pre-Market Approval
    FDA Class 3 ·AMPLATZER Duct Occluder and AMPLATZER Duct Occluder II

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE® Injectable Implant

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·AMPLATZER Septal Occluder and AMPLATZER Multi-Fenestrated Septal Occluder

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems

    Lens, Intraocular, Accommodative

    FDA Pre-Market Approval
    FDA Class 3 ·CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·Prostar XL 10F Percutaneous Vascular Surgical System

    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    FDA Pre-Market Approval
    FDA Class 3 ·AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (AngioSculpt Evo catheter)

    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

    FDA Pre-Market Approval
    FDA Class 3 ·PulseSelect™ Pulsed Field Ablation (PFA) system

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·EXPRESS 2 CORNARY STENT SYSTEM

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·LCS TOTAL KNEE SYSTEM

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

    System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·ColoSense

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Collamer Intraocular Lens (CIOL)

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

    Lens, Intraocular, Phakic

    FDA Pre-Market Approval
    FDA Class 3 ·Visian Implantable Collamer Lens (ICL)