BEUDAMED
    9,694 results · 38ms · Sources: EU EUDAMED, US FDA

    CN23/00002940

    Certificate
    MDR QMS·APT Medical Inc.·SGS Belgium NV

    CN19/41142

    Certificate
    MDD Annex II Section 4·APT Medical Inc.·SGS Belgium NV·8 Basic UDI-DIs

    CN19/41145

    Certificate
    MDD Annex II Section 4·APT Medical Inc.·SGS Belgium NV·10 Basic UDI-DIs

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards SAPIEN 3™ Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra™ Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra™

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Evolut FX+ TAV, Evolut FX DCS, Evolut FX LS

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·CoreValve™ EnVeo™ R Delivery Catheter System, CoreValve™ EnVeo™ PRO Delivery Catheter System, Evolut™ PRO+ Delivery Cath

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valves

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo Pro Delivery Catheter System, Evolut PRO+ Delivery Catheter

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·COREVALVE (TM) EVOLUTE (TM) R SYSTEM

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Commander delivery system (Size 29mm)

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·LOTUS Edge Valve System

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Medtronic Evolut R Transcatheter Aortic Valve Replacement System, Medtronic Evolut PRO Transcatheter Aortic Valve Replac

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·CoreValve Evolut R System, CoreValve Evolut PRO and Wvolut PRO+ Transcatheter Aortic Valves (TAV)

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS SAPIEN TRANSCATHER HEART VALVE

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Ascendra+ Delivery System; Balloon Aortic Valvuloplasty Catheter; NovaFlex+ Delivery System; Crimper; Edwards Ballon Cat

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Sapien 3 Transcatheter Heart Valve