BEUDAMED
    20 results · 32ms · Sources: EU EUDAMED, US FDA

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    AIR MOTOR HANDPIECE TN-102

    FDA 510(k)
    FDA Class 1 ·Dental

    Sklar Instruments

    FDA UDI
    SKLAR CORPORATION·10649111055393·ECONO STERILE STRABIS SCISS STR 4.5"STER 25

    Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX

    FDA 510(k)
    FDA Class 2 ·Dental

    OsteoMed PINNACLE Driver

    FDA 510(k)
    FDA Class 2 ·Neurology

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 15, 2023

    Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRABIS SCISS STR 4.5"STER 25, Model Number 96-2542; 4) ECONO STERILE STRABISMUS SCISS STR4.5"CS/25, Model Number 96-2542M; eye surgery

    FDA Enforcement
    Class II ·Ongoing·Sklar Instruments·January 22, 2025

    PROMUS ELEMENT¿ PLUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·February 14, 2013

    INRATIO

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code GJS·January 7, 2011

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·June 30, 2014

    CONTOUR ACETABULAR RECONSTRUCTION RING

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDJ·June 6, 2025

    MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDJ·January 23, 2026

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·July 26, 2024

    NSK

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EFB·September 17, 2025

    BA102

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EGS·March 31, 2016

    BA105

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EGS·March 28, 2016

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 18, 2019

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·August 29, 2017

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 18, 2019

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 18, 2019

    Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRABIS SCISS STR 4.5"STER 25, Model Number 96-2542; 4) ECONO STERILE STRABISMUS SCISS STR4.5"CS/25, Model Number 96-2542M; eye surgery

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code HNF·December 3, 2024