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

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    PRISMA M10 PRE SET

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

    MEDRAD STELLANT CT INJECTOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THERMAGE THERMACOOL II SYSTEM

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

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·September 3, 2018

    ELITE HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS·Product code KWY·April 17, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·April 12, 2011

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·June 20, 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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015