BEUDAMED
    348 results · 36ms · Sources: EU EUDAMED, US FDA

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    SPACER BLOCK HANDLE - 8MM/9MM

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·May 22, 2013

    LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging

    FDA Enforcement
    Class II ·Terminated·89 NORTH·September 2, 2020

    ORSIRO 3.5/30

    FDA Adverse Event
    Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code NIQ·March 20, 2024

    MARK II INFLATABLE PENILE PROSTHESIS

    FDA Adverse Event
    Injury ·MENTOR UUROLOGY, INC.·Product code FHW·November 5, 1996

    LARYNGEAL MASK AIRWAY

    FDA Adverse Event
    Injury ·THE LARYNGEAL MASK CO·Product code CAE·January 12, 2001

    ORSIRO MISSION US 3.5/22

    FDA Adverse Event
    Malfunction ·BIOTRONIK AG·Product code NIQ·January 9, 2026

    ACRYSOF

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LTD/HUNTINGTON·Product code HQL·August 19, 2011

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·CODMAN AND SHURTLEFF, INC·Product code NJE·December 23, 2015

    BINAXNOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 3, 2022

    BINAXNOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 3, 2022

    IMPELLA CP

    FDA Adverse Event
    Injury ·ABIOMED·Product code OZD·April 9, 2019

    NONE

    FDA Adverse Event
    Death ·ACMI·Product code MCJ·May 12, 1992

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Injury ·DEXCOM, INC.·Product code QBJ·November 6, 2024

    PREMIER NITROSPRAY PLUS LITE

    FDA Adverse Event
    Malfunction ·PREMIER MEDICAL MANUFACTURING·Product code GEH·December 21, 2010

    Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.

    FDA Enforcement
    Class I ·Terminated·BARD PERIPHERAL VASCULAR, INC·January 25, 2017

    LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging

    FDA Recall
    Terminated ·Product code REK·January 31, 2020

    CARELINK

    FDA Adverse Event
    Injury ·MEDTRONIC INC.·Product code KRG·April 25, 2018

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·February 20, 2015

    ARROW CATH-LAB SHEATH INTRO SET

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code DQY·July 24, 2023

    PALL RCXL1 LEUKOCYTE REDUCTION FILTER FOR RED CELL TRANSFUSN

    FDA Adverse Event
    Other ·PALL BIOMEDICAL PRODUCTS CO.·Product code CAK·March 3, 1997