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

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    ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    n/a

    FDA UDI
    HANS RUDOLPH, INC.·00874750006939·4830B NON HEATED PNT

    Working Tube

    FDA UDI
    ELLIQUENCE, LLC·00846338003067·

    FIXTEMP C&B

    FDA 510(k)
    FDA Class 2 ·Dental

    DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CODA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·October 23, 2017

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014

    CENTRA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·May 25, 2011

    CODA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·September 10, 2019

    THERMAGE CPT SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL·Product code GEI·May 25, 2018

    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

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025