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

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    SKYLINE 55, MODEL VER 1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ULTRASONIC NEBULIZER, MODEL NE-520

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LOWSLEY SUPRAPUBIC TRACTOR

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

    STRYKER REJUVENATE MODULAR STEM IMPLANT

    FDA Adverse Event
    STRYKER ORTHOPAEDICS·Product code MEH·April 29, 2013

    BIODESIGN POSTERIOR PELVIC FLOOR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH, INC.·Product code PAG·August 21, 2014

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·April 27, 2011

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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