BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    OLYMPUS ENDOARM

    FDA 510(k)
    FDA Class 2 ·Neurology

    N LATEX LP(A)

    FDA 510(k)
    FDA Class 2 ·Immunology

    MODIFICATION TO RELIEF BRIEF

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 9, 2013

    PULSE GEN MODEL 103

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·March 25, 2011

    VITALITY DS VR

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak Nebulizer Adaptor 028, Sterile, Shelfpak, Product No. 031-28 & 031-28F, Aqaupak Nebulizer Adaptor 033, Sterile, Shelfpak, Product No. 031-33; Aqaupak Nebulizer Adaptor 033, Sterile, Japanese, Product No. 031-33J. Used in anesthesiology.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 10, 2014

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012