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

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    OCEAN CHEST DRAIN

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MAYBE?MOM MINI OVULATION MICROSCOPE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01

    FDA 510(k)
    FDA Class 2 ·General Hospital

    1043582-1999-00001

    FDA Adverse Event
    Injury ·Product code GCY·June 23, 1999

    CONTAK TR

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NKE·April 9, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 28, 2014

    ENDOTAK RELIANCE

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

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

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

    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