BEUDAMED
    8,447 results · 30ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Eyhance™ IOL with TECNIS Simplicity™ Delivery System, Model DIB00, TECNIS Eyhance™ Toric II IOLs with TECNIS Simp

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD and Impella 5.5 with SmartAssist Systems

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·JJSV's One-Piece IOL's with Daisy-Whell packaging configuration, JJSV's One-Piece IOLs with TECNIS SmartLOAD Delivery Te

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·IMPELLA 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with SmartAssist System, and

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Synergy IOL with TECNIS Simplicity Delivery System, TECNIS Synergy Toric II IOL with TECNIS Simplicity Delivery S

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP and Impella RP with SmartAssist

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·iPro2 CGM System with Enlite Glucose Sensor

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, CP, and CP with SmartAssist

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·APS III PROGRAMMER WITH MODEL 3303 SOFTWARE

    Lens, Contact (Rigid Gas Permeable), Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·VISIONS MADE WITH PARAGON HDS (PAFLUFOCON B)

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·GORE Viabahn Endoprosthesis with Heparin Bioactive Surface

    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Gore Viabahn Endoprosthesis with Heparin Bioactive Surface

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Trifecta Valve with Glide Technology (Trifecta GT)

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 Artificial Urinary Sphincter with InhibiZone™

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·POWERLINK SYSTEM WITH INTUI TRAK DELIVERY SYSTEM

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER SYSTEM