BEUDAMED
    117 results · 22ms · Sources: EU EUDAMED, US FDA

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    Prosthesis, Ankle, Uncemented, Non-Constrained

    FDA Pre-Market Approval
    FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

    Prosthesis, Ankle, Uncemented, Non-Constrained

    FDA Pre-Market Approval
    FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

    Prosthesis, Ankle, Uncemented, Non-Constrained

    FDA Pre-Market Approval
    FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

    Prosthesis, Ankle, Uncemented, Non-Constrained

    FDA Pre-Market Approval
    FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

    Prosthesis, Ankle, Uncemented, Non-Constrained

    FDA Pre-Market Approval
    FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

    Prosthesis, Ankle, Uncemented, Non-Constrained

    FDA Pre-Market Approval
    FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707017127·CALIBRA 1ST MOLAR BANDS n.LR 36

    VIVID POST WHITE

    FDA UDI
    BIOLOREN SRL·08056099233180·Cylindrical fiberglass posts ø 1.4 mm.

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694035774·4/6 Cannulated Depth Gauge, Double Sided

    SEE H10

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·October 23, 2017

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS INTUITY ELITE VALVE SYSTEM

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA PD-L1 (SP142) Assay

    SEE H10

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·December 1, 2016

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 10, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011

    PROLIEVE THERMODILITATION KIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·September 12, 2008

    HEART-VALVE, REPLACEMENT

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·August 29, 2019

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code OTE·June 11, 2025

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Intuity Elite Valve System

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS INTUITY Elite Valve