BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 2, 2019

    MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT

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

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·April 11, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·March 1, 2011

    EZ HUBER SAFETY INFUSION SET

    FDA Adverse Event
    Malfunction ·PFM MEDICAL, INC·Product code FMI·May 28, 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