BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    SAF (SELF ADJUSTING FILE)

    FDA 510(k)
    FDA Class 1 ·Dental

    EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    INFINION 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 16, 2022

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·May 3, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·September 16, 2014

    HEARTMATE II SYSTEM CONTROLLER, EU

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·April 11, 2011

    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