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

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    AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10

    FDA 510(k)
    FDA Class 2 ·Immunology

    ORTHOPILOT

    FDA 510(k)
    FDA Class 2 ·Neurology

    VITAL STIM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CONTOUR TEST STRIPS

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·May 25, 2012

    CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·April 8, 2013

    SEXTANT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·October 1, 2010

    REFLEX ULTRA PTR WITH INTEGRATED CABLE

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code GEI·April 11, 2013

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH DURAFLO TRE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·June 19, 2008

    STAIR PRO - MODEL 6252

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPP·April 11, 2011

    OSSEOTITE CERTAIN IMPLANT 4 X 11.5MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·December 18, 2023

    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