BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    CORONARY ANASTOMOSIS MARKING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    1077 EARTIP 8-11 TRANS 50 PCS

    FDA UDI
    PATH medical GmbH·04260223141263·

    FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE

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

    KATALYST RADIAL HEAD IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 27, 2014

    POWERED WHEELCHAIR

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

    PRESEP - CENTRAL VENOUS OXIMETRY KIT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DQE·September 13, 2010

    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