BEUDAMED
    14 results · 25ms · Sources: EU EUDAMED, US FDA

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    INTRA-AORTIC BALLOON (IAB)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    Summit Medical, Inc.·00385640001182·

    Disposable Cuff

    FDA UDI
    SUNTECH MEDICAL, INC.·10840935103752·

    Summit Medical

    FDA UDI
    Summit Medical, Inc.·00385640068901·

    BD¿ ENTERAL SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·February 13, 2023

    PC COATED FLUOROPLASTIC VENT TUBES

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    T2 FEMORAL NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA UDI
    USA INSTRUMENTS, INC.·00840682145602·

    FUSION TITAN DILATION BALLOON

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FGE·May 4, 2018

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 6, 2011

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·April 8, 2013

    9600EMI

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·May 9, 2008

    PF-VIRTEC SYSTEM CMTED LAT.6

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code LZO·August 6, 2019

    GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 2038437-0XX; 9) 2098071-004; 10) 2109571-002; 11) 2109571-006; 12) 2109571-010; 13) 2109594-009; 14) 2109594-011; 15) K2090PS; 16) K2090PTED; 17) MANLEGACY114; 18) MANLEGACY64.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·April 9, 2025