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

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    RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM

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

    MODIFICATION TO CLEARFIL SE BOND

    FDA 510(k)
    FDA Class 2 ·Dental

    E.S.O. (ELECTRO SENSOR OXI)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AQUILEX FLUID CONTROL SYSTEM

    FDA Adverse Event
    Malfunction ·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020

    M2A 38MM MOD HD+6MM NK NO SKRT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 14, 2013

    BRILLIIANCE EBW

    FDA Adverse Event
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code JAK·March 22, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

    FLEXI SEAL SIGNAL (FMS)

    FDA Adverse Event
    Injury ·CONVATEC INC.·Product code KNT·October 11, 2016

    EMBLEM S-ICD Model A209

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