BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Genius Total Knee System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215022525·

    CYTOFLEX

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDLINK DIAGNOSTIC OFFLINE WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    PEN NEEDLE 31GX5MM 5B TW 98CT CHINA

    FDA Adverse Event
    Malfunction ·EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA·Product code FMI·April 21, 2025

    INFUSE BONE GRAFT/LT-CAGE

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code NEK·November 12, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code MAF·April 28, 2011

    CAPSURE Z

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 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

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020