BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    APC FLASH-FREE ADHESIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    Seatpillow Maquet Transfer Board

    FDA UDI
    Noras MRI products GmbH·04251269204777·

    WS-501 HEAT LAMP

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EXACTECH GIBRALT SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 9, 2025

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 28, 2014

    PLUM Y-BLOOD SET W/FLR CLAVE 110IN NDEHP

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·May 8, 2013

    ASR ACETABULAR IMPLANT 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD·Product code KWA·May 20, 2011

    VERSAFITCUP DM CEMENTLESS ACETABULAR SHELL

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 12, 2013

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·May 17, 2019

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·March 18, 2019

    OPTILITE SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·June 5, 2020

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·March 12, 2019

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·March 18, 2019

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Injury ·COOK INC·Product code GEX·November 4, 2022

    OPTILITE SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·February 13, 2020

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021