BEUDAMED
    23 results · 21ms · Sources: EU EUDAMED, US FDA

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    APEX

    FDA 510(k)
    FDA Class 2 ·Radiology

    CLEARARCH

    FDA 510(k)
    FDA Class 2 ·Dental

    VIVAWAVE MICROWAVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PRECISION? MONTAGE? MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 3, 2025

    KRD DEVICE, EMBOLIZATION, VASCULAR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRD·September 19, 2019

    LS LF MB EXT SET CLAVE LSC T

    FDA Adverse Event
    Malfunction ·HOSPIRA, LTD·Product code FPA·May 7, 2013

    ACCU-CHEK VOICEMATE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 13, 2008

    PHILIPS TELEMON

    FDA Adverse Event
    Death ·PHILIPS HEALTHCARE·Product code DSI·May 27, 2011

    VITEK® 2 AST-ST01 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code LON·October 24, 2017

    RETRACTA DETACHABLE EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·June 20, 2019

    AXIOM Sireskop SX Model numbers 3111676 and 3111668. The product is intended for use as radiographic and fluoroscopic imaging device.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code JAA·January 8, 2009

    RETRACTA DETACHABLE EMBOLIZATION COIL

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRD·September 17, 2018

    RETRACTA DETACHABLE EMBOLIZATION COIL

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRD·September 17, 2018

    RETRACTA DETACHABLE EMBOLIZATION COIL

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRD·January 2, 2020

    RETRACTA DETACHABLE EMBOLIZATION COIL

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRD·January 2, 2020

    RETRACTA DETACHABLE EMBOLIZATION COIL

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRD·March 11, 2020

    RETRACTA DETACHABLE EMBOLIZATION COIL

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRD·July 31, 2019

    RETRACTA DETACHABLE EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·February 25, 2019

    RETRACTA DETACHABLE EMBOLIZATION COIL

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRD·February 3, 2020

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018