BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    VIATRONIX VISUALIZATION SYSTEM (VVS)

    FDA 510(k)
    FDA Class 2 ·Radiology

    INVIRO SNAP SAFETY SYRINGE, 1CC, 3CC, 5CC, AND 10CC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 27, 2025

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·April 23, 2013

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·April 29, 2011

    MAXIMO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·July 10, 2008

    FLEX ARM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·August 1, 2017

    FLEX ARM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·July 24, 2017

    Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure table mounting for minimally invasive spine surgery. The Flex Arm is designed to hold Synthes Minimally Invasive Retractors, which are connected to the Flex Arm by adapters.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 2, 2018

    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