BEUDAMED
    7,420 results · 36ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MRP-20: HS/MR HEAD COIL 3-D FT RECONSTRUCTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    LEAD ENGUARD BIF PF DFT

    FDA Adverse Event
    Injury ·TELECTRONICS PACING SYSTEMS·Product code DTB·April 8, 1997

    PRISMALIX 6401 SAL/DF/T

    FDA Adverse Event
    Malfunction ·MAQUET SAS·Product code FSY·May 9, 2017

    LEAD ENGUARD BIF PF DFT 100

    FDA Adverse Event
    Injury ·TELECTRONICS PACING SYSTEMS·Product code DTB·April 8, 1997

    LEAD ENGUARD BIF PF DFT 100

    FDA Adverse Event
    Injury ·TELECTRONICS·Product code DTB·March 15, 1997

    IMMUNOGLOBULIN M

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DFT·April 9, 2024

    S-ICD SYSTEM

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 26, 2018

    ELLIPSE VR ICD, US

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code LWS·July 6, 2023

    EMBLEM S-ICD

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·June 24, 2024

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 30, 2014

    ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.

    FDA Enforcement
    Class II ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·September 19, 2018

    ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.

    FDA Recall
    Terminated ·Micro Therapeutics Inc, Dba Ev3 Neurovascular·Product code MCW·August 10, 2018

    EMBLEM MRI S-ICD

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·November 21, 2024

    EMBLEM MRI S-ICD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·April 27, 2021

    EMBLEM S-ICD

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·May 6, 2021

    EMBLEM MRI S-ICD

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·September 28, 2023

    EMBLEM S-ICD

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·September 28, 2023

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code LWS·April 27, 2018

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·November 7, 2013

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 21, 2010