BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    L'DISQ

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

    DELIGHT DENTAL ER: YAG LASER SYSTEM

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

    PLM A+ SPANISH DEVIC

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 17, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·November 14, 2012

    GUIDER SOFTIP GUIDING CATHETERS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·September 13, 2010

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·December 2, 2024

    8110 ALARIS SYRINGE PUMP

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·January 8, 2021

    8110 ALARIS SYRINGE PUMP

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·January 8, 2021

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014