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

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    AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MODIFICATION TO: THERMACOOL IIA

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

    COLTENE AURA COMPOMER RESTORATIVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    UNKNOWN

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·September 9, 2016

    GRAFTYS BCP (510K NUMBER: K073064)

    FDA Adverse Event
    Injury ·GRAFTYS·Product code MQV·July 11, 2013

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·April 6, 2013

    SM104 MSERIES W5TH WHL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·April 21, 2011

    RIATA ST OPTIM ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

    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